510(k) clearances for Dilator, Vessel, For Percutaneous Catheterization
105 on file
- Merit Medical Systems, Inc.Jul 27, 2026
K261310 · FlexTract Deflectable-Rotational Dilator Sheath Set
- Sorin Group Italia S.R.L.Dec 19, 2025
K253616 · ProtekDilate Vascular Access Kit
- Baylis Medical Company, Inc.May 29, 2025
K251325 · VersaCross Connect Transseptal Dilator
- Merit Medical Systems, Inc.Jan 15, 2025
K242229 · Micro Ace Gold Advanced Micro Access System
- Baylis Medical Company, Inc.Jul 12, 2024
K241720 · VersaCross Connect Transseptal Dilator
- Baylis Medical Company, Inc.Dec 14, 2023
K233647 · VersaCross Connect Transseptal Dilator
- Merit Medical Systems, Inc.Sep 27, 2023
K232609 · Micro Ace Advanced Micro Access System
- Spectranetics, Inc.Dec 15, 2022
K223472 · TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian Motorized Dilator Sheath, 11 French (575-011); TightRail Guardian Motorized Dilator Sheath, 13 French (575-013)
- Spectranetics, Inc.Aug 24, 2022
K212784 · TightRail Guardian Motorized Dilator Sheath
- Xcardia Innovation , Ltd.Feb 17, 2022
K211679 · Xtractor device
- Cook IncorporatedApr 6, 2021
K210734 · Endovascular Dilator and Sets
- Baylis Medical Company, Inc.Jun 12, 2020
K201288 · ExpanSure Large Access Transseptal Dilator
- Medron, LLCMay 6, 2020
K192283 · MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator
- Togo Medikit Co., Ltd.Mar 19, 2020
K200379 · Super Sheath
- Galt Medical Corp.Sep 26, 2019
K192195 · Sterile Dilator
- Merit Medical Systems, Inc.Apr 10, 2019
K190175 · S-MAK XL
- Baylis Medical Company, Inc.Mar 21, 2019
K182064 · ExpanSure Transseptal Dilation System
- Cook IncorporatedDec 20, 2018
K183036 · Dilator Sets
- Mc3 IncorporatedOct 29, 2018
K182914 · MC3 Vascular Access Kit 21030
- Galt Medical Corp.Oct 16, 2017
K172487 · Coaxial Dilator Set (Micro-Introducer)
- Medcomp ( Medical Components)Jun 1, 2017
K162389 · Medcomp Vessel Dilator
- Cook IncorporatedApr 28, 2017
K170616 · van Andel Dilatation Catheter
- Cardiacassist, Inc.Jan 6, 2017
K162181 · Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set
- Vascular Solutions, Inc.Aug 11, 2016
K161336 · VSI StraitSet micro-introducer kit
- Bioteque Corp.Jul 22, 2016
K150932 · Sheath Introducer
- Spectranetics, Inc.Jul 8, 2016
K161333 · TightRail Sub-C Rotating Dilator Sheath
- Arstasis, Inc.Aug 7, 2015
K151877 · MicroTract Access System
- Summit Access, LLCMay 22, 2015
K151076 · MicroTaper Needle Introducer Set
- Spectranetics, Inc.Mar 4, 2015
K150360 · TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator Sheath
- Togo Medikit Co., Ltd.Jan 15, 2015
K141070 · SUPER SHEATH
- Cook Vascular, Inc.Nov 12, 2014
K142301 · Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath Set, SteadySheath Evolution Tissue Stabilization Sheath, SteadySheath Evolution Shortie Tissue Stabilization Sheath
- Spectranetics, Inc.Sep 25, 2014
K142546 · TightRail Rotating Dilator Sheath/TightRail Mini Dilator Sheath
- Cook Vascular, Inc.Jul 1, 2014
K141148 · EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET
- Spectranetics, Inc.May 23, 2014
K141131 · TIGHTRAIL MINI
- Spectranetics Corp.Apr 9, 2014
K140047 · LEXICONTURE MECHANICAL DILATOR SHEATH SET
- Spectranetics CorporationMar 27, 2014
K133631 · LEXIPLIANT DILATOR SHEATH SET
- Navilyst Medical, Inc.Sep 27, 2013
K132713 · NMI COAXIAL MICROINTRODUCER SET
- Lifetech Scientific (Shenzhen) Co., Ltd.Jun 24, 2013
K123842 · LAWMAX DILATOR
- Merit Medical Systems, Inc.Jun 7, 2013
K130791 · PRELUDE SHEATH INTRODUCER
- Navilyst Medical, Inc.Apr 1, 2013
K123445 · NMI COAXIAL MICROINTRODUCER SET
- Ultrasonix Medical CorpationApr 9, 2012
K120349 · SONIXGPS VASCULAR ACCESS NEEDLE KIT
- Arstasis, Inc.May 24, 2011
K103421 · ARSTASIS DILATOR ADAPTER
- Edwards Lifesciences, LLCApr 13, 2010
K093554 · RETROFLEX DILATOR KIT
- Spectranetics Corp.Nov 2, 2009
K092378 · SPECTRANETICS VISISHEATH DILATOR SHEATH
- Merit Medical Systems, Inc.Oct 9, 2009
K091584 · MERIT MAK (MINI ACCESS KIT) WITH PALLADIUM TIP GUIDE WIRE
- Avalon Laboratories, LLCNov 18, 2008
K081940 · AVALON ELITE VASCULAR ACCESS KIT
- Hansen Medical, Inc.Aug 15, 2008
K082075 · HANSEN MEDICAL DILATOR FOR ARTISAN CONTROL CATHETER
- Merit Medical Systems, Inc.Nov 20, 2007
K073035 · PRELUDE AND PRELUDE PRO SHEATH INTRODUCERS
- Galt Medical Corp.Oct 31, 2007
K071330 · GALTSTICK INTRODUCER SYSTEM
- Coombs Medical Device ConsultingOct 24, 2007
K070749 · ESTECH PERCUTANEOUS INSERTION DILATOR KIT
- Merit Medical Systems, Inc.Jun 21, 2007
K070159 · PRELUDE SHEATH INTRODUCER
- Abbott Vascular, Inc.Feb 6, 2007
K062554 · STARCLOSE HEX-HUB DILATOR
- Cook Vascular, Inc.May 10, 2006
K061000 · EVOLUTION MECHANICAL DILATOR SHEATH SET MODELS-LR-EVN-7.0, LR-EVN-9.0
- Togo Medikit Co., Ltd.Jan 17, 2006
K052557 · SUPER SHEATH INTRODUCER SHEATH
- Merit Medical Systems, Inc.May 6, 2005
K050962 · MERIT PRELUDE SHEATH INTRODUCER
- Merit Medical Systems, Inc.Sep 3, 2003
K031691 · MERIT MAK (MINI ACCESS KIT)
- Vascumetrix, LLCFeb 20, 2003
K030260 · GELBFISH FLEX VASCULAR DILATOR
- Vascumetrix, LLCNov 8, 2002
K023507 · MODIFICATION TO GELBFISH VASCULAR DILATORS
- Vascumetrix, LLCDec 20, 2001
K012256 · GELBISH VASCULAR DILATOR
- Cook Vascular, Inc.Jun 14, 2001
K010055 · COOK VASCULAR ELECTROSURGICAL DISSECTION SHEATH
- Xentek Medical, Inc.Aug 1, 2000
K000737 · COAXIAL DILATOR SET
- Endovascular Instruments, Inc.Dec 1, 1998
K974617 · PERIPHERAL VASCULAR DILATOR
- Uresil Corp.Apr 24, 1998
K980282 · URESIL DILATOR WITH RADIOPAQUE MARKER
- Boston Scientific CorpMar 13, 1998
K974640 · COAXIAL DILATOR SET
- Guidant Cardiac and Vascular SurgeryJul 31, 1997
K970470 · EVT EXPANDABLE SHEATH
- Cordis Corp.Apr 24, 1997
K970392 · CORDIS AVANTI+CATHETER SHEATH INTRODUCER SYSTEM
- Med Institute, Inc.Apr 4, 1997
K945586 · FLEXIBLE DILATING SHEATH
- Maxxim MedicalMar 11, 1997
K963388 · VESSEL DILATOR
- Scientific Device Manufacturer, LLCJul 2, 1996
K960917 · PERCUGLIDE
- Med Institute, Inc.Jan 3, 1992
K914555 · WORKSTATION FEMORAL INTRAVASCULAR RETRIEVAL (MODI)
- Deseret Medical, Inc.Nov 27, 1991
K913027 · VESSEL DILATOR
- Novaste Corp.Oct 9, 1991
K912050 · NOVOSTE VESSEL DILATER
- The R GroupMar 25, 1991
K905416 · VESSEL DILATOR
- Datascope Corp.Dec 10, 1990
K904476 · VESSEL DILATOR
- Medical Engineering and Development InstituteAug 23, 1990
K902469 · BYRD DILATOR SHEATH SET - TEFLON
- Pioneering Technologies, Inc.Jul 3, 1990
K901815 · MODIFIED STERILIZATION OF INTRA-ART(TM) CORONARY
- Microvena Corp.Apr 10, 1990
K896096 · SOLOSTICK (AMPLATZ DILATOR NEEDLE)
- Daig Corp.Sep 12, 1989
K894330 · DAIG VESSEL DILATOR
- Ideal Medical, Inc.Aug 25, 1988
K882238 · VESSEL DILATOR AND INTRODUCER SHEATH
- Shiley, Inc.Jun 9, 1988
K881073 · SHILEY FEMORAL CANNULAE INTRODUCER KIT
- Impra, Inc.May 2, 1988
K874738 · 10 AND 12 FRENCH VESSEL DILATORS
- Schneider-Shilley (Usa)Mar 25, 1988
K875327 · MODIFIED SELDINGER INITIAL PUNCTURE INSTRUMENT
- Med-West, Inc.Sep 15, 1987
K872724 · SHEATH/DILATORS
- Medical Surgical Concepts, Inc.Jun 1, 1987
K870413 · PERCUTANEOUS SHEATH W/WO MEDI. (5,6,7,8,8.5FR)
- Uresil Corp.Apr 22, 1987
K871148 · URESIL CAROTID ARTERY SIZERS
- Quinton, Inc.Aug 19, 1986
K862288 · MODIFICATION OF TISSUE DILATOR
- Medical Design Concepts, Inc.May 2, 1986
K860161 · HEART CATHETERIZATION TRAY
- Marwood Medical, Inc.Feb 25, 1985
K850337 · CARDIAC CATHETERIZATION PACK
- Angiosystems, Inc.Sep 11, 1984
K843261 · ANGIOSYSTEMS STANDARD ARTERIOGRAM & CARD
- Mallinckrodt Critical CareJul 13, 1984
K842113 · AMENDMENT TO ANGIOGRAPHY KIT W/ADDIT
- Quinton, Inc.Jul 2, 1984
K841995 · 10.5 FRENCH DILATOR, 15CM, W/LUER LOCK
- Professional Medical ServicesMar 12, 1984
K840671 · CARDIAC CATHETERIZATION PACK
- Medi-Plast Intl., Inc.Feb 4, 1984
K840022 · HEART CATHETERIZATION TRAY SET
- Professional Medical ServicesFeb 4, 1984
K840017 · VERTEX PERCUTANEOUS CATHETER INTRODUC
- Quinton, Inc.Dec 16, 1983
K833965 · 8 FRENCH DILATOR 15CM, W/LUER LOCK
- Medrad, Inc.May 9, 1983
K831190 · VESSEL DILATOR
- Vertex Medical Corp.Sep 28, 1982
K822595 · VESSEL DILATOR
- Ocean Medical Products, Ltd.Dec 29, 1981
K813461 · PERCUTANEOUS ENTRY NEEDLE, SELDINGER
- Honeywell, Inc.Dec 14, 1981
K813125 · MICRO TRANSDUCER CATHETERS
- Procedure Products, Inc.Apr 11, 1981
K810859 · SINGLE USE SELDINGER/COURNAND PERC. NDL
- Stanco Medical, Inc.Oct 10, 1980
K802327 · SHEATH DILATOR SET
- Alva Medical, Inc.Jul 28, 1980
K801113 · DILATOR, VESSEL, FOR PERC. CATHETER.
- Medical Components, Inc.Mar 19, 1980
K800462 · PERCUTANEOUS INTRODUCER SET
- Argon Medical Corp.Mar 2, 1978
K780126 · DILATOR, VESSEL & INTRODUCER, SHEATH
- Usci, Div. C.R. Bard, Inc.Aug 23, 1976
K760403 · TEMPORARY ATRIAL ELECTRODE KIT