510(k) clearances for Catheter, Peripheral, Atherectomy
146 on file
- Eximo MedicalApr 10, 2026
K260244 · Auryon Atherectomy System
- Cardio Flow Inc.,Apr 25, 2025
K250723 · FreedomFlow Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)
- SpectraneticsMar 13, 2025
K250385 · Turbo-Elite Laser Atherectomy Catheter
- Bard Peripheral Vascular, Inc.Jan 30, 2025
K242757 · Rotarex Atherectomy System
- Cardio Flow Inc.,Nov 5, 2024
K242947 · FreedomFlow Orbital Circumferential Atherectomy System
- Eximo Medical, Ltd.Jun 27, 2024
K241553 · Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating
- Cardio Flow Inc.,Feb 15, 2024
K233483 · FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)
- Eximo Medical, Ltd.Dec 15, 2023
K233668 · Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon Atherectomy Catheter 0.9 mm XL, Hydrophilic Coating (EXM-4011-H000), Auryon Atherectomy Catheter 1.5 mm XL (EXM -4010-0000), Auryon Atherectomy Catheter 0.9 mm XL (EXM-4011-0000)
- Cardio Flow Inc.,Sep 27, 2023
K231538 · FreedomFlow Orbital Circumferential Atherectomy System
- Eximo Medical, Ltd.Jun 9, 2023
K230709 · Auryon Atherectomy System
- Avinger, Inc.Jun 6, 2023
K230005 · Pantheris LV Atherectomy Catheter
- Spectranetics, Inc.Dec 8, 2022
K222837 · Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters
- Eximo Medical, Ltd.Sep 26, 2022
K220116 · Auryon Atherectomy Catheters
- Boston Scientific CorporationSep 6, 2022
K220962 · ROTAPRO Rotational Atherectomy System
- Eximo Medical, Ltd.Jun 9, 2022
K221077 · Auryon Atherectomy System
- Cardiovascualr Systems, Inc.Apr 27, 2022
K220568 · Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series
- Cardiovascular Systems, Inc.Mar 1, 2022
K220109 · DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System
- Rex Medical, L.P.Dec 15, 2021
K212351 · Revolution Peripheral Atherectomy System
- Avinger, Inc.Nov 16, 2021
K212047 · Pantheris System
- C.R. Bard, Inc.Sep 14, 2021
K211738 · Rotarex Atherectomy System
- Cardiovascular Systems, Inc.Sep 14, 2021
K210586 · Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system
- Medtronic, Inc.Aug 24, 2021
K212027 · TurboHawk Plus Directional Atherectomy System
- Volcano Atheromed, Inc.Jun 14, 2021
K211518 · 2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy System
- Eximo Medical, Ltd.Dec 2, 2020
K202835 · Auryon Atherectomy System
- Cardiovascular Systems, Inc.Nov 19, 2020
K203008 · DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System
- Rex Medical, L.P.Sep 12, 2019
K191419 · Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire
- Cardiovascular Systems, Inc.Jul 2, 2019
K190634 · Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System
- Avinger, Inc.Apr 9, 2019
K182341 · Pantheris SV
- Volcano Atheromed, Inc.Dec 20, 2018
K182972 · Phoenix Atherectomy System
- Volcano Atheromed, Inc.Dec 17, 2018
K181877 · Phoenix 2.4mm Atherectomy Plus System
- Cardiovascular Systems, Inc.Dec 13, 2018
K182397 · Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series
- Eximo Medical, Ltd.Oct 5, 2018
K181642 · B-Laser Atherectomy System
- Avinger, Inc.May 22, 2018
K173862 · Pantheris System
- Cardiovascular Systems, Inc.Apr 17, 2018
K180416 · ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System
- Straub Medical AGApr 12, 2018
K172315 · Straub Endovascular System
- Spectranetics, Inc.Apr 5, 2018
K180694 · Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters
- Spectranetics, Inc.Nov 27, 2017
K172687 · Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters
- Avinger, Inc.Oct 30, 2017
K172236 · Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled
- Volcano Atheromed, Inc.Aug 24, 2017
K172386 · 1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System
- Medtronic Vascular, Inc.Jun 16, 2017
K170191 · SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System
- Cardiovascular Systems, Inc.Jun 9, 2017
K170792 · Diamondback 360 Peripheral Orbital Atherectomy System
- Spectranetics, Inc.Apr 7, 2017
K170059 · Spectranetics Turbo-Elite Laser Atherectomy Catheters
- Spectranetics, Inc.Jan 5, 2017
K162561 · Turbo-Power (2.0mm) Laser Atherectomy Catheters
- Avinger, Inc.Dec 21, 2016
K163264 · Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox Sled
- Avinger, Inc.Oct 18, 2016
K162326 · Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled
- Medtronic Vascular, Inc.Oct 14, 2016
K161361 · HawkOne Directional Atherectomy System
- Avinger, Inc.Apr 21, 2016
K160827 · Pantheris Catheter
- Avinger, Inc.Mar 1, 2016
K153460 · Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)
- Spectranetics, Inc.Nov 12, 2015
K152181 · Turbo-Power Laser Atherectomy Catheter
- Cardiovascular Systems, Inc.Oct 21, 2015
K152694 · Diamondback 360 Peripheral Orbital Atherectomy System
- Avinger, Inc.Oct 14, 2015
K152275 · Pantheris System
- Cardiovascular System, Inc.Jun 10, 2015
K151260 · ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PAD
- Volcano Atheromed, Inc.May 26, 2015
K151145 · 2.4mm X 127 cm Phoenix Atherectomy Deflecting System
- Cardiovascular Systems, Inc.Apr 13, 2015
K150732 · Diamondback 360 Peripheral Orbital Atherectomy System
- Volcano Atheromed, Inc.Dec 19, 2014
K143328 · 1.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire Support Clip
- Covidien, LLCOct 16, 2014
K141801 · HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM
- Medrad, Inc.Aug 27, 2014
K133023 · JETSTREAM XC 2.4/3.4; JETSTREAM XC 2.1/3.0; JETSTREAM SC 1.85; JETSTREAM SC 1.6
- Atheromed, Inc.Aug 22, 2014
K140944 · 1.8 MM PHOENIX ATHERECTOMY CATHETER, 2.2 MM PHOENIX ATHERECTOMY CATHETER, PHOENIX HANDLE, PHOENIX WIRE SUPPORT CLIP
- Spectranetics CorporationJul 23, 2014
K140775 · TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEM
- Cardiovascular Systems, Inc.Feb 28, 2014
K133999 · DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
- Atheromed, Inc.Jan 17, 2014
K132682 · PHOENIX 5F TRACKING ATHERECTOMY CATHETER, PHOENIX 6F TRACKING ATHERECTOMY CATHETER, PHOENIX 7D DEFLECTING ATHERECTOMY CA
- Boston Scientific CorpDec 20, 2013
K133566 · ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH THE PERIPHERAL ROTALINK PLUS
- Cardiovascular Systems IncorporatedNov 22, 2013
K133399 · DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
- Cardio Systems, Inc.Jun 24, 2013
K131092 · STEALTH 360 ORBITAL PAD SYSTEM
- Medrad, Inc.Apr 10, 2013
K130637 · JETSTREAM XC 2.4/3.4 SYSTEM; JETSTREAM XC 2.1/3.0 SYSTEM; JETSTREAM SC 1.85 SYSTEM; JETSTREAM SC 1.6 SYSTEM
- Spectranetics Corp.Jan 25, 2013
K123632 · 2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035
- Cardiovascular Systems, Inc.Oct 25, 2012
K122987 · STEALTH 360 ORBITAL PAD SYSTEM
- Medrad, Inc.Oct 19, 2012
K122916 · JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEM
- Boston Scientific CorpSep 13, 2012
K121774 · ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH PERIPHERAL ROTALINK PLUS
- Rex MedicalJun 1, 2012
K120346 · CLEANER ROTATIONAL THROMBECTOMY SYSTEM
- Pathway Medical Technologies, Inc.Feb 24, 2012
K120242 · JETSTREAM NAVITUS L SYSTEM
- Ev3, Inc.Oct 27, 2011
K111723 · TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM
- Cardiovascular Systems, Inc.Jul 26, 2011
K111388 · DIAMONDBACK 360* ORBITAL ATHERECTOMY SYSTEM, STEALTH 360* ORBITAL PAD SYSTEM
- Pathway Medical Technologies, Inc.Jun 1, 2011
K111229 · JETSTREAM G3 (R) SF 1.6 SYSTEM
- Pathway Medical Technologies, Inc.Apr 20, 2011
K110626 · JETSTREAM NAVITUS SYSTEM; JETSTREAM G3 SF SYSTEM; JETSTREAM G3 SE SYSTEM; JETSTREAM G3 L SYSTEM
- Cardiovascular Systems, Inc.Mar 11, 2011
K110389 · STEALTH 360 ORBITAL PAD SYSTEM
- Ev3, Inc.Jan 5, 2011
K103618 · TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEM
- Pathway Medical Technologies, Inc.Jun 11, 2010
K101334 · JETSTREAM G3 SE SYSTEM, JETSTREAM G3 SF SYSTEM MODEL PV31230 (JETSTREAM G3 SE CATHETER AND CONTROL POD); PVCN100 (PV CON
- Pathway Medical Technologies, Inc.Jun 2, 2010
K101221 · JETSTREAM G3 SYSTEM, MODEL PV31300, PV CONSOLE, MODEL PVCN100
- Pathway Medical Technologies, Inc.May 19, 2010
K100462 · JETSTREAM G3 L SYSTEM, PV CONSOLE, MODELS PV31400, PV31300, PVCN100
- Rex MedicalFeb 18, 2010
K091029 · CLEANER ROTATIONAL THROMBECTOMY SYSTEM (9 MM X 65 CM) AND (9 MM X 120 CM)
- Spectranetics Corp.Jan 25, 2010
K094036 · TURBO-TANDEM SYSTEM MODEL 472-110
- Pathway Medical Technologies, Inc.Jan 21, 2010
K093918 · JETSTREAM G3 L SYSTEM MODEL PV31400 (JETSTREAM G3 L CATHETER WITH CONTROL POD); PVCN100 (PV CONSOLE)
- Pathway Medical Technologies, Inc.Dec 1, 2009
K093456 · JETSTREAM G3 SYSTEM
- Ev3, Inc.Nov 6, 2009
K093301 · TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM
- Pathway Medical Technologies, Inc.Sep 3, 2009
K092332 · JETSTREAM G3 SYSTEM, MODEL PV31300 ( JETSTREAM G3 CATHETER AND CONTROL POD)., PVCN100 (PV CONSOLE)
- Pathway Medical Technologies, Inc.Jun 19, 2009
K091509 · JETSTREAM G2 NXT SYSTEM, MODEL PV20300
- Cardiovascular Systems, Inc.Mar 20, 2009
K090521 · DIAMONDBACK 360 DBX
- Pathway Medical Technologies, Inc.Mar 11, 2009
K090325 · JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD); PVCN100 (PV CONSOLE)
- Pathway Medical Technologies, Inc.Jan 23, 2009
K083489 · JETSTREAM PATHWAY PC ATHERECTOMY SYSTEM, MODEL OV10300
- Pathway Medical Technologies, Inc.Jan 13, 2009
K083837 · JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD); PVCN100 (PV CONSOLE)
- Cardiovascular Systems, Inc.Oct 31, 2008
K082981 · DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM WITH VIPERSLIDE LUBRICANT
- Pathway Medical Technologies, Inc.Oct 6, 2008
K082664 · JETSTREAM PATHWAY PV ATHERECTOMY SYSTEM, MODEL PV10300, PVCN100
- Pathway Medical Technologies, Inc.Aug 29, 2008
K082186 · MODIFICATION TO PATHWAY PV ATHERECTOMY SYSTEM
- Cardio Systems, Inc.Aug 14, 2008
K081944 · MODIFICATION TO DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM
- Pathway Medical Technologies, Inc.Jul 17, 2008
K081328 · PATHWAY PV ATHERECTOMY SYSTEM
- Fox Hollow TechnologiesFeb 12, 2008
K071432 · SILVERHAWK-R PERIPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE
- Cardiovascular Systems, Inc.Nov 9, 2007
K072748 · MODIFICATION TO: DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM
- Cardiovascular Systems, Inc.Oct 25, 2007
K072800 · DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM
- Cardiovascular Systems, Inc.Aug 30, 2007
K071427 · DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS
- Kensey Nash Corp.Aug 23, 2007
K072195 · THROMCAT THROMBECTOMY CATHETER SYSTEM
- Cardiovascular Systems, Inc.Aug 22, 2007
K071350 · DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM
- Foxhollow Technologies, Inc.Oct 23, 2006
K061188 · SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM
- Foxhollow Technologies, Inc.May 18, 2006
K061063 · MODIFICATION TO: SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS P4028/FG08300
- Rex Medical, L.P.Apr 28, 2006
K060904 · CLEANER ROTATIONAL THROMBECTOMY SYSTEM
- Kensey Nash Corp.Apr 25, 2006
K060016 · THROMCAT THROMBECTOMY CATHETER SYSTEM
- Fox Hollow TechnologiesJan 13, 2006
K053460 · MODIFICATION TO SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550, 04800, 05200, 06002, 02406, 04706, 04300,
- Fox Hollow TechnologiesFeb 18, 2005
K043553 · SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550,04800, 05200, 02406, 04706, 04300
- Cardiovascular Systems IncorporatedJan 31, 2005
K041630 · ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS
- Ev3 CorporationSep 8, 2004
K021096 · X-SIZER CATHETER SYSTEM
- Rex MedicalFeb 26, 2004
K040252 · CLEANER ROTATIONAL THROMBECTOMY SYSTEM KIT
- Bacchus Vascular, Inc.Feb 4, 2004
K033997 · SOLERA PLUS THROMBECTOMY CATHETER, 55 CM AND 110 CM, MODELS BAC SMG 007 055, BAC SMG 007 110
- Rex MedicalDec 16, 2003
K033793 · CLEANER II ROTATIONAL THROMBECTOMY SYSTEM
- Idev Technologies, Inc.Sep 16, 2003
K030504 · AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL 10060060
- Fox Hollow TechnologiesJun 20, 2003
K024243 · REFORM PERIPHERAL CATHETER SYSTEM, MODEL 02200; REFORM PERIPHERAL CATHETERCATHETER, MODEL 02406
- Rex MedicalMay 27, 2003
K031610 · REX MEDICAL CLEANER ROTATIONAL THROMBECTOMY SYSTEM
- Bacchus Vascular, Inc.Dec 2, 2002
K022640 · SOLERA MAGNUM THROMBECTOMY CATHETER, 55 CM, MODEL BAC SMG 007 055 & SOLERA MAGNUM THROMBECTOMY CATHETER, 110 CM
- Xtrak Medical, Inc.Mar 6, 2002
K013473 · XTD THROMBECTOMY CATHETER, XX CM, MODEL# CT000500X; XTD CONTROL CONSOLE, MODEL # CT0006001; XTD COLLECTION BOTTLE, MODEL
- Bacchus Vascular, Inc.Jun 6, 2001
K003570 · BACCHUS THROMBECTOMY CATHETER (BTC), MODEL BTC-0755
- Baxter EdwardsMay 4, 2000
K993816 · BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AND PMT1206FD
- Possis Medical, Inc.Apr 28, 2000
K993564 · POSSIS ANGIOJET X-STREAM RHEOLYTIC THROMBECTOMY CATHETER, MODEL 103587-002
- Boston Scientific Corporation Northwest TechnologyNov 24, 1999
K993648 · ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER
- Arrow Intl., Inc.May 4, 1999
K990829 · ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD, MODELS PT-45509 (CATHETER KIT WITH INTRODUCER SHEATHS),PT-65
- Boston Scientific CorpFeb 23, 1999
K982363 · OASIS THROMBECTOMY CATHETER SYSTEM
- Microvena Corp.Nov 18, 1998
K982657 · AMPLATZ THROMBECTOMY DEVICE MODELS ATD 601, ATD 602, ATD 801, ATD 802, FOOT PEDAL ASSEMBLY MODEL AK 100
- Micro Therapeutics, Inc.Feb 6, 1998
K973669 · THROMBOLYTIC BRUSH CATHETER, OVER THE WIRE (OTW)
- Gary A. GelbfishOct 8, 1997
K970233 · GELBFISH ENDO-VAC SYSTEM
- Microvena Corp.Sep 19, 1997
K971984 · AMPLATZ THROMBECTOMY DEVICE(ATD 603,602,801,802)/FOOT PEDAL ASSEMBLY(AK 200)
- Boston Scientific CorpAug 29, 1997
K970296 · ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER
- Micro Therapeutics, Inc.Aug 8, 1997
K963925 · THROMBOLYTIC BRUSH CATHETER
- Arrow Intl., Inc.Jul 25, 1997
K970080 · ARROW-TREROTOLA PTD CATHETER
- Possis Medical, Inc.Dec 3, 1996
K960970 · POSSIS ANGIOJET RAPID THROMBECTOMY CATHETER SYSTEM, F105 CATHETER,MODEL 3030C,LF140 CATHETER,MODEL 3040C,PUMP SET 3020P
- Microvena Corp.Aug 13, 1996
K954205 · THE AMPLATZ THROMBECTOMY DEVICE
- Heart Technology Mfg., Inc.Apr 25, 1996
K960379 · ROTABLATOR SYSTEM'S GUIDE WIRE LINE: SUPPORT ROTAWIRE RAIL ROTA WIRE
- Heart Technology Mfg., Inc.Jan 18, 1996
K954604 · ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM ROTABLATOR SYSTEM'S GUIDE WIRE LINE; HTI FLOPPY
- Heart Technology Mfg., Inc.Dec 22, 1995
K953997 · ROTABLATOR ROTATIONAL ANGIOPLASTY
- Intramed Laboratories, Inc.Feb 7, 1995
K942457 · GRAFT THROMBECTOMY INSTRUMENTS
- Devices For Vascular Intervention, Inc.Mar 10, 1994
K935929 · MICROTRACK
- Heart Technology, Inc.Aug 24, 1993
K933238 · ROTABLATOR, MODIFICATION
- Intensive Technology, Inc.Jan 13, 1993
K922970 · INTRA-OPERATIVE TEC ATHERECTOMY SYSTEM
- Hearing Tech, Inc.Dec 8, 1992
K924712 · ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM
- Devices For Vascular Intervention, Inc.Nov 23, 1992
K920707 · HOLLOW MOTOR DRIVE UNIT W/ TORQUE CONTROLLER
- Dow Corning WrightFeb 19, 1992
K915238 · TRAC-WRIGHT TRAC 10 CATHETER
- Heart Technology, Inc.Sep 6, 1991
K913450 · HEART TECHNOLOGY ROTABLATOR WIRECLIP
- Dow Corning WrightDec 27, 1990
K904680 · THERATEK GROUP EXCHANGE CATHETER
- Heart Technology, Inc.Sep 14, 1990
K901206 · ROTABLATOR