510(k) clearances for Catheter For Crossing Total Occlusions
57 on file
- AngioSafe, Inc.Sep 22, 2025
K252315 · Santreva-ATK Endovascular Revasculariztion Catheter
- Baylis Medical Technologies, Inc.Sep 11, 2025
K251158 · PowerWire® 14 Radiofrequency Guidewire Kit
- LimFlow, Inc.May 31, 2025
K251376 · LimFlow ARC
- Baylis Medical Technologies, Inc.Feb 28, 2024
K232562 · PowerWire Radiofrequency Guidewire Kit
- Soundbite Medical Solutions, Inc.Aug 28, 2023
K230159 · SoundBite® Crossing System XS Peripheral
- Avinger, Inc.Apr 25, 2023
K230594 · Tigereye ST CTO-Crossing Catheter
- Tractus Vascular, LLCJan 19, 2023
K221163 · Tunnel Crossing Catheter
- LimFlow, Inc.Aug 31, 2022
K221541 · LimFlow ARC
- Ra Medical Systems,IncJun 29, 2022
K220544 · DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)
- Upstream Peripheral Technologies, Ltd.Mar 1, 2022
K211802 · GoBack Crossing Catheter
- Avinger, Inc.Jan 6, 2022
K212468 · Tigereye CTO-Crossing Catheter
- C.R. Bard, Inc.Aug 12, 2021
K203363 · Crosser iQ CTO Recanalization System
- Ra Medical Systems,IncJul 27, 2021
K210664 · DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)
- Soundbite Medical Solutions, Inc.Apr 20, 2021
K210839 · SoundBite Crossing System - Peripheral (14P)
- Avinger, Inc.Sep 10, 2020
K201330 · Tigereye CTO-Crossing Catheter
- Soundbite Medical Solution, Inc.Jan 17, 2020
K192211 · SoundBite Console, SoundBite Active Wire 18
- Xablecath, Inc.Jan 21, 2019
K183357 · XableCath Crossing Catheter
- Ra Medical Systems,IncMay 24, 2017
K170349 · RA-308 Excimer Laser System, Excimer Laser Catheter
- Philips VolcanoDec 2, 2016
K162418 · Pioneer Plus Catheter
- Bard Peripheral Vacular, Inc.May 24, 2016
K161208 · CROSSER CTO Recanalization Catheter
- Cordis Corporation, A Johnson & Johnson CompanyMay 19, 2015
K150187 · ELITECROSS Support Catheter
- Cordis Corporation, A Johnson & Johnson Co.Apr 29, 2015
K150836 · OUTBACK Elite Re-Entry Catheter
- Cordis Corp., A Johnson & Johnson Co.Nov 14, 2014
K140438 · MICRO GUIDE CATHETER ELITE
- Avinger, Inc.May 1, 2014
K140185 · OCELOT CATHETER, OCELOT PIXL CATHETER, LIGHTBOX CONSOLE
- Boston Scientific CorpApr 16, 2014
K140288 · TRUEPATH CTO DEVICE
- Boston Scientific CorpOct 31, 2013
K131914 · OFFROAD RE-ENTRY CATHETER SYSTEM
- Avinger, Inc.Dec 14, 2012
K123532 · OCELOT PIXL CATHETER
- Avinger, Inc.Dec 7, 2012
K123462 · OCELOT CATHETER
- Avinger, Inc.Nov 7, 2012
K122380 · OCELOT SYSTEM
- Bridgepoint MedicalMay 22, 2012
K120533 · BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRES
- Avinger, Inc.Mar 30, 2012
K120273 · KITTYCAT CATHETER, KITTYCAT 2 CATHETER
- Avinger, Inc.Mar 12, 2012
K113838 · WILDCAT CATHETER
- C.R. Bard, Inc.Aug 17, 2011
K112308 · CROSSER RECANALIZATION SYSTEM
- Avinger, Inc.Aug 11, 2011
K111338 · WILDCAT CATHETER
- Revascular Therapeutics, Inc.Jan 18, 2011
K101599 · RVT CTO DEVICE
- Baylis Medical Co., Inc.Jul 28, 2010
K101615 · POWERWIRE RADIOFREQUENCY GUIDEWIRE
- Medtronic VascularJul 23, 2010
K101777 · PIONEER PLUS CATHETER, MODEL PLUS 120
- Flowcardia, Inc.Feb 17, 2010
K092175 · THE CROSSER S6 CATHETER, THE CROSSER SYSTEM ELECTRONICS, MODEL CRUS6, GEN200
- Flowcardia, Inc.May 15, 2009
K091119 · MODIFICATION TO THE CROSSER SYSTEM
- Cordis Corp., A Johnson & Johnson Co.Jan 13, 2009
K083814 · OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB42120
- Cordis Corp.Aug 25, 2008
K082143 · MICRO GUIDE CATHETER XP
- Medtronic, Inc.Aug 5, 2008
K081804 · PIONEER PLUS CATHETER
- Flowcardia, Inc.Dec 7, 2007
K072776 · THE CROSSER SYSTEM
- Medtronic, Inc.Oct 5, 2007
K072155 · PIONEER CATHETER
- Spectranetics Corp.Jul 11, 2007
K071227 · CLIRPATH TURBO EXCIMER LASER CATHETER (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM, (RX) -2.0MM, MODEL 310-154, 314-159, 317-15
- Spectranetics Corp.Jun 29, 2007
K071226 · 8FR TURBO BOOSTER, GUIDE CATHETER, 7FR TURBO BOOSTER, MODEL 518-063, 518-043
- Spectranetics Corp.Sep 29, 2006
K060012 · CLIRPATH TURBO PERIPHERAL CATHETERS
- Baylis Medical Co., Inc.Mar 30, 2006
K051670 · RF TUNNELER WIRE
- Spectranetics Corp.Oct 19, 2005
K052514 · CLIRPATH TURBO PLUS EXCIMER LASER CATHETERS, MODELS 314-151, 314-159, 317-152, 317-156, 320-006, 320-159, 323-001
- Spectranetics Corp.Sep 2, 2005
K052296 · CLIRPATH TURBO EXCIMER LASER CATHETERS
- Spectranetics Corp.Aug 18, 2005
K043465 · 2.5 MM TURBO CLIRPATH EXCIMER LASER CATHETER, MODEL 225-011
- Intra Luminal Therapeutics, Inc.Jun 8, 2005
K050916 · SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [PERIPHERAL]
- Spectranetics Corp.Apr 27, 2004
K040067 · CLIRPATH EXCIMER LASER CATHETER
- Lumend, Inc.Jan 7, 2004
K033535 · LUMEND FRONTRUNNER CTO CATHETER AND ACCESSORIES
- Intra Luminal Therapeutics, Inc.Nov 21, 2003
K031842 · SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
- Lumend, Inc.Jun 18, 2003
K031005 · LUMEND FRONTRUNNER GW CTO CATHETER
- Lumend, Inc.Jan 23, 2003
K023114 · LUMEND FRONTRUNNER CTO CATHETER