| Santreva™-ATK Endovascular Revasculariztion Catheter (K252315) | AngioSafe, Inc. | 2025-09-22 |
| PowerWire® 14 Radiofrequency Guidewire Kit (K251158) | Baylis Medical Technologies, Inc. | 2025-09-11 |
| LimFlow ARC (K251376) | LimFlow, Inc. | 2025-05-31 |
| PowerWire Radiofrequency Guidewire Kit (K232562) | Baylis Medical Technologies, Inc. | 2024-02-28 |
| SoundBite® Crossing System XS Peripheral (K230159) | Soundbite Medical Solutions, Inc. | 2023-08-28 |
| Tigereye ST CTO-Crossing Catheter (K230594) | Avinger, Inc. | 2023-04-25 |
| Tunnel Crossing Catheter (K221163) | Tractus Vascular, LLC | 2023-01-19 |
| LimFlow ARC (K221541) | LimFlow, Inc. | 2022-08-31 |
| DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0) (K220544) | Ra Medical Systems,Inc | 2022-06-29 |
| GoBack Crossing Catheter (K211802) | Upstream Peripheral Technologies, Ltd. | 2022-03-01 |
| Tigereye CTO-Crossing Catheter (K212468) | Avinger, Inc. | 2022-01-06 |
| Crosser iQ CTO Recanalization System (K203363) | C.R. Bard, Inc. | 2021-08-12 |
| DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101) (K210664) | Ra Medical Systems,Inc | 2021-07-27 |
| SoundBite Crossing System - Peripheral (14P) (K210839) | Soundbite Medical Solutions, Inc. | 2021-04-20 |
| Tigereye CTO-Crossing Catheter (K201330) | Avinger, Inc. | 2020-09-10 |
| SoundBite Console, SoundBite Active Wire 18 (K192211) | Soundbite Medical Solution, Inc. | 2020-01-17 |
| XableCath Crossing Catheter (K183357) | Xablecath, Inc. | 2019-01-21 |
| RA-308 Excimer Laser System, Excimer Laser Catheter (K170349) | Ra Medical Systems,Inc | 2017-05-24 |
| Pioneer Plus Catheter (K162418) | Philips Volcano | 2016-12-02 |
| CROSSER CTO Recanalization Catheter (K161208) | Bard Peripheral Vacular, Inc. | 2016-05-24 |
| ELITECROSS Support Catheter (K150187) | Cordis Corporation, A Johnson & Johnson Company | 2015-05-19 |
| OUTBACK Elite Re-Entry Catheter (K150836) | Cordis Corporation, A Johnson & Johnson Co. | 2015-04-29 |
| MICRO GUIDE CATHETER ELITE (K140438) | Cordis Corp., A Johnson & Johnson Co. | 2014-11-14 |
| OCELOT CATHETER, OCELOT PIXL CATHETER, LIGHTBOX CONSOLE (K140185) | Avinger, Inc. | 2014-05-01 |
| TRUEPATH CTO DEVICE (K140288) | Boston Scientific Corp | 2014-04-16 |
| OFFROAD RE-ENTRY CATHETER SYSTEM (K131914) | Boston Scientific Corp | 2013-10-31 |
| OCELOT PIXL CATHETER (K123532) | Avinger, Inc. | 2012-12-14 |
| OCELOT CATHETER (K123462) | Avinger, Inc. | 2012-12-07 |
| OCELOT SYSTEM (K122380) | Avinger, Inc. | 2012-11-07 |
| BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRES (K120533) | Bridgepoint Medical | 2012-05-22 |
| KITTYCAT CATHETER, KITTYCAT 2 CATHETER (K120273) | Avinger, Inc. | 2012-03-30 |
| WILDCAT CATHETER (K113838) | Avinger, Inc. | 2012-03-12 |
| CROSSER RECANALIZATION SYSTEM (K112308) | C.R. Bard, Inc. | 2011-08-17 |
| WILDCAT CATHETER (K111338) | Avinger, Inc. | 2011-08-11 |
| RVT CTO DEVICE (K101599) | Revascular Therapeutics, Inc. | 2011-01-18 |
| POWERWIRE RADIOFREQUENCY GUIDEWIRE (K101615) | Baylis Medical Co., Inc. | 2010-07-28 |
| PIONEER PLUS CATHETER, MODEL PLUS 120 (K101777) | Medtronic Vascular | 2010-07-23 |
| THE CROSSER S6 CATHETER, THE CROSSER SYSTEM ELECTRONICS, MODEL CRUS6, GEN200 (K092175) | Flowcardia, Inc. | 2010-02-17 |
| MODIFICATION TO THE CROSSER SYSTEM (K091119) | Flowcardia, Inc. | 2009-05-15 |
| OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB42120 (K083814) | Cordis Corp., A Johnson & Johnson Co. | 2009-01-13 |
| MICRO GUIDE CATHETER XP (K082143) | Cordis Corp. | 2008-08-25 |
| PIONEER PLUS CATHETER (K081804) | Medtronic, Inc. | 2008-08-05 |
| THE CROSSER SYSTEM (K072776) | Flowcardia, Inc. | 2007-12-07 |
| PIONEER CATHETER (K072155) | Medtronic, Inc. | 2007-10-05 |
| CLIRPATH TURBO EXCIMER LASER CATHETER (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM, (RX) -2.0MM, MODEL 310-154, 314-159, 317-15 (K071227) | Spectranetics Corp. | 2007-07-11 |
| 8FR TURBO BOOSTER, GUIDE CATHETER, 7FR TURBO BOOSTER, MODEL 518-063, 518-043 (K071226) | Spectranetics Corp. | 2007-06-29 |
| CLIRPATH TURBO PERIPHERAL CATHETERS (K060012) | Spectranetics Corp. | 2006-09-29 |
| RF TUNNELER WIRE (K051670) | Baylis Medical Co., Inc. | 2006-03-30 |
| CLIRPATH TURBO PLUS EXCIMER LASER CATHETERS, MODELS 314-151, 314-159, 317-152, 317-156, 320-006, 320-159, 323-001 (K052514) | Spectranetics Corp. | 2005-10-19 |
| CLIRPATH TURBO EXCIMER LASER CATHETERS (K052296) | Spectranetics Corp. | 2005-09-02 |
| 2.5 MM TURBO CLIRPATH EXCIMER LASER CATHETER, MODEL 225-011 (K043465) | Spectranetics Corp. | 2005-08-18 |
| SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [PERIPHERAL] (K050916) | Intra Luminal Therapeutics, Inc. | 2005-06-08 |
| CLIRPATH EXCIMER LASER CATHETER (K040067) | Spectranetics Corp. | 2004-04-27 |
| LUMEND FRONTRUNNER CTO CATHETER AND ACCESSORIES (K033535) | Lumend, Inc. | 2004-01-07 |
| SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM (K031842) | Intra Luminal Therapeutics, Inc. | 2003-11-21 |
| LUMEND FRONTRUNNER GW CTO CATHETER (K031005) | Lumend, Inc. | 2003-06-18 |
| LUMEND FRONTRUNNER CTO CATHETER (K023114) | Lumend, Inc. | 2003-01-23 |