FDA Product Code
FDA Product Code PDU — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1250
510(k) Clearances — 58 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262013 | Kiba CTO Crossing Catheter | Reflow Medical, Inc. | 2026-08-28 | Special | PDF ↗ |
| K252315 | Santreva-ATK Endovascular Revasculariztion Catheter | AngioSafe, Inc. | 2025-09-22 | Traditional | PDF ↗ |
| K251158 | PowerWire® 14 Radiofrequency Guidewire Kit | Baylis Medical Technologies, Inc. | 2025-09-11 | Traditional | PDF ↗ |
| K251376 | LimFlow ARC | LimFlow, Inc. | 2025-05-31 | Special | PDF ↗ |
| K232562 | PowerWire Radiofrequency Guidewire Kit | Baylis Medical Technologies, Inc. | 2024-02-28 | Traditional | PDF ↗ |
| K230159 | SoundBite® Crossing System XS Peripheral | Soundbite Medical Solutions, Inc. | 2023-08-28 | Traditional | PDF ↗ |
| K230594 | Tigereye ST CTO-Crossing Catheter | Avinger, Inc. | 2023-04-25 | Traditional | PDF ↗ |
| K221163 | Tunnel Crossing Catheter | Tractus Vascular, LLC | 2023-01-19 | Traditional | PDF ↗ |
| K221541 | LimFlow ARC | LimFlow, Inc. | 2022-08-31 | Traditional | PDF ↗ |
| K220544 | DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0) | Ra Medical Systems,Inc | 2022-06-29 | Traditional | PDF ↗ |
| K211802 | GoBack Crossing Catheter | Upstream Peripheral Technologies, Ltd. | 2022-03-01 | Traditional | PDF ↗ |
| K212468 | Tigereye CTO-Crossing Catheter | Avinger, Inc. | 2022-01-06 | Traditional | PDF ↗ |
| K203363 | Crosser iQ CTO Recanalization System | C.R. Bard, Inc. | 2021-08-12 | Traditional | PDF ↗ |
| K210664 | DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101) | Ra Medical Systems,Inc | 2021-07-27 | Traditional | PDF ↗ |
| K210839 | SoundBite Crossing System - Peripheral (14P) | Soundbite Medical Solutions, Inc. | 2021-04-20 | Special | PDF ↗ |
| K201330 | Tigereye CTO-Crossing Catheter | Avinger, Inc. | 2020-09-10 | Traditional | PDF ↗ |
| K192211 | SoundBite Console, SoundBite Active Wire 18 | Soundbite Medical Solution, Inc. | 2020-01-17 | Traditional | PDF ↗ |
| K183357 | XableCath Crossing Catheter | Xablecath, Inc. | 2019-01-21 | Traditional | PDF ↗ |
| K170349 | RA-308 Excimer Laser System, Excimer Laser Catheter | Ra Medical Systems,Inc | 2017-05-24 | Traditional | PDF ↗ |
| K162418 | Pioneer Plus Catheter | Philips Volcano | 2016-12-02 | Special | PDF ↗ |
| K161208 | CROSSER CTO Recanalization Catheter | Bard Peripheral Vacular, Inc. | 2016-05-24 | Special | PDF ↗ |
| K150187 | ELITECROSS Support Catheter | Cordis Corporation, A Johnson & Johnson Company | 2015-05-19 | Traditional | PDF ↗ |
| K150836 | OUTBACK Elite Re-Entry Catheter | Cordis Corporation, A Johnson & Johnson Co. | 2015-04-29 | Special | PDF ↗ |
| K140438 | MICRO GUIDE CATHETER ELITE | Cordis Corp., A Johnson & Johnson Co. | 2014-11-14 | Traditional | PDF ↗ |
| K140185 | OCELOT CATHETER, OCELOT PIXL CATHETER, LIGHTBOX CONSOLE | Avinger, Inc. | 2014-05-01 | Traditional | PDF ↗ |
| K140288 | TRUEPATH CTO DEVICE | Boston Scientific Corp | 2014-04-16 | Special | PDF ↗ |
| K131914 | OFFROAD RE-ENTRY CATHETER SYSTEM | Boston Scientific Corp | 2013-10-31 | Traditional | PDF ↗ |
| K123532 | OCELOT PIXL CATHETER | Avinger, Inc. | 2012-12-14 | Special | PDF ↗ |
| K123462 | OCELOT CATHETER | Avinger, Inc. | 2012-12-07 | Special | PDF ↗ |
| K122380 | OCELOT SYSTEM | Avinger, Inc. | 2012-11-07 | Traditional | PDF ↗ |
| K120533 | BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRES | Bridgepoint Medical | 2012-05-22 | Traditional | PDF ↗ |
| K120273 | KITTYCAT CATHETER, KITTYCAT 2 CATHETER | Avinger, Inc. | 2012-03-30 | Traditional | PDF ↗ |
| K113838 | WILDCAT CATHETER | Avinger, Inc. | 2012-03-12 | Traditional | PDF ↗ |
| K112308 | CROSSER RECANALIZATION SYSTEM | C.R. Bard, Inc. | 2011-08-17 | Traditional | PDF ↗ |
| K111338 | WILDCAT CATHETER | Avinger, Inc. | 2011-08-11 | Traditional | PDF ↗ |
| K101599 | RVT CTO DEVICE | Revascular Therapeutics, Inc. | 2011-01-18 | Traditional | PDF ↗ |
| K101615 | POWERWIRE RADIOFREQUENCY GUIDEWIRE | Baylis Medical Co., Inc. | 2010-07-28 | Special | PDF ↗ |
| K101777 | PIONEER PLUS CATHETER, MODEL PLUS 120 | Medtronic Vascular | 2010-07-23 | Special | PDF ↗ |
| K092175 | THE CROSSER S6 CATHETER, THE CROSSER SYSTEM ELECTRONICS, MODEL CRUS6, GEN200 | Flowcardia, Inc. | 2010-02-17 | Traditional | PDF ↗ |
| K091119 | MODIFICATION TO THE CROSSER SYSTEM | Flowcardia, Inc. | 2009-05-15 | Special | PDF ↗ |
| K083814 | OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB42120 | Cordis Corp., A Johnson & Johnson Co. | 2009-01-13 | Traditional | PDF ↗ |
| K082143 | MICRO GUIDE CATHETER XP | Cordis Corp. | 2008-08-25 | Special | PDF ↗ |
| K081804 | PIONEER PLUS CATHETER | Medtronic, Inc. | 2008-08-05 | Traditional | PDF ↗ |
| K072776 | THE CROSSER SYSTEM | Flowcardia, Inc. | 2007-12-07 | Traditional | PDF ↗ |
| K072155 | PIONEER CATHETER | Medtronic, Inc. | 2007-10-05 | Traditional | PDF ↗ |
| 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. | 2007-07-11 | Traditional | PDF ↗ |
| K071226 | 8FR TURBO BOOSTER, GUIDE CATHETER, 7FR TURBO BOOSTER, MODEL 518-063, 518-043 | Spectranetics Corp. | 2007-06-29 | Traditional | PDF ↗ |
| K060012 | CLIRPATH TURBO PERIPHERAL CATHETERS | Spectranetics Corp. | 2006-09-29 | Traditional | PDF ↗ |
| K051670 | RF TUNNELER WIRE | Baylis Medical Co., Inc. | 2006-03-30 | Traditional | PDF ↗ |
| K052514 | CLIRPATH TURBO PLUS EXCIMER LASER CATHETERS, MODELS 314-151, 314-159, 317-152, 317-156, 320-006, 320-159, 323-001 | Spectranetics Corp. | 2005-10-19 | Traditional | PDF ↗ |
| K052296 | CLIRPATH TURBO EXCIMER LASER CATHETERS | Spectranetics Corp. | 2005-09-02 | Traditional | PDF ↗ |
| K043465 | 2.5 MM TURBO CLIRPATH EXCIMER LASER CATHETER, MODEL 225-011 | Spectranetics Corp. | 2005-08-18 | Traditional | PDF ↗ |
| K050916 | SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [PERIPHERAL] | Intra Luminal Therapeutics, Inc. | 2005-06-08 | Special | PDF ↗ |
| K040067 | CLIRPATH EXCIMER LASER CATHETER | Spectranetics Corp. | 2004-04-27 | Traditional | PDF ↗ |
| K033535 | LUMEND FRONTRUNNER CTO CATHETER AND ACCESSORIES | Lumend, Inc. | 2004-01-07 | Special | PDF ↗ |
| K031842 | SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM | Intra Luminal Therapeutics, Inc. | 2003-11-21 | Traditional | PDF ↗ |
| K031005 | LUMEND FRONTRUNNER GW CTO CATHETER | Lumend, Inc. | 2003-06-18 | Special | PDF ↗ |
| K023114 | LUMEND FRONTRUNNER CTO CATHETER | Lumend, Inc. | 2003-01-23 | Traditional | PDF ↗ |
Product code PDU · Class II · Cardiovascular. Data: openFDA.