Product code PDU
- Device name
- Catheter For Crossing Total Occlusions
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.1250
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- To facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including subchronic and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention, such as angioplasty, atherectomy or stent placement.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252315 | Santreva™-ATK Endovascular Revasculariztion Catheter | AngioSafe, Inc. | 2025-09-22 |
| K251158 | PowerWire® 14 Radiofrequency Guidewire Kit | Baylis Medical Technologies, Inc. | 2025-09-11 |
| K251376 | LimFlow ARC | LimFlow, Inc. | 2025-05-31 |
| K232562 | PowerWire Radiofrequency Guidewire Kit | Baylis Medical Technologies, Inc. | 2024-02-28 |
| K230159 | SoundBite® Crossing System XS Peripheral | Soundbite Medical Solutions, Inc. | 2023-08-28 |
| K230594 | Tigereye ST CTO-Crossing Catheter | Avinger, Inc. | 2023-04-25 |
| K221163 | Tunnel Crossing Catheter | Tractus Vascular, LLC | 2023-01-19 |
| K221541 | LimFlow ARC | LimFlow, Inc. | 2022-08-31 |
| K220544 | DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0) | Ra Medical Systems,Inc | 2022-06-29 |
| K211802 | GoBack Crossing Catheter | Upstream Peripheral Technologies, Ltd. | 2022-03-01 |
| K212468 | Tigereye CTO-Crossing Catheter | Avinger, Inc. | 2022-01-06 |
| K203363 | Crosser iQ CTO Recanalization System | C.R. Bard, Inc. | 2021-08-12 |
| K210664 | DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101) | Ra Medical Systems,Inc | 2021-07-27 |
| K210839 | SoundBite Crossing System - Peripheral (14P) | Soundbite Medical Solutions, Inc. | 2021-04-20 |
| K201330 | Tigereye CTO-Crossing Catheter | Avinger, Inc. | 2020-09-10 |
| K192211 | SoundBite Console, SoundBite Active Wire 18 | Soundbite Medical Solution, Inc. | 2020-01-17 |
| K183357 | XableCath Crossing Catheter | Xablecath, Inc. | 2019-01-21 |
| K170349 | RA-308 Excimer Laser System, Excimer Laser Catheter | Ra Medical Systems,Inc | 2017-05-24 |
| K162418 | Pioneer Plus Catheter | Philips Volcano | 2016-12-02 |
| K161208 | CROSSER CTO Recanalization Catheter | Bard Peripheral Vacular, Inc. | 2016-05-24 |
| K150187 | ELITECROSS Support Catheter | Cordis Corporation, A Johnson & Johnson Company | 2015-05-19 |
| K150836 | OUTBACK Elite Re-Entry Catheter | Cordis Corporation, A Johnson & Johnson Co. | 2015-04-29 |
| K140438 | MICRO GUIDE CATHETER ELITE | Cordis Corp., A Johnson & Johnson Co. | 2014-11-14 |
| K140185 | OCELOT CATHETER, OCELOT PIXL CATHETER, LIGHTBOX CONSOLE | Avinger, Inc. | 2014-05-01 |
| K140288 | TRUEPATH CTO DEVICE | Boston Scientific Corp | 2014-04-16 |
| K131914 | OFFROAD RE-ENTRY CATHETER SYSTEM | Boston Scientific Corp | 2013-10-31 |
| K123532 | OCELOT PIXL CATHETER | Avinger, Inc. | 2012-12-14 |
| K123462 | OCELOT CATHETER | Avinger, Inc. | 2012-12-07 |
| K122380 | OCELOT SYSTEM | Avinger, Inc. | 2012-11-07 |
| K120533 | BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRES | Bridgepoint Medical | 2012-05-22 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07540299000488 | PowerWire 14 Radiofrequency Guidewire Kit | Baylis Medical Technologies Inc | 2025-12-04 |
| 07540299000471 | PowerWire 14 Radiofrequency Guidewire Kit | Baylis Medical Technologies Inc | 2025-12-04 |
| 07540299000433 | PowerWire 14 Radiofrequency Guidewire Kit | Baylis Medical Technologies Inc | 2025-12-04 |
| 07540299000426 | PowerWire 14 Radiofrequency Guidewire Kit | Baylis Medical Technologies Inc | 2025-12-04 |
| 00845225003425 | Pioneer Plus Catheter | Philips Image Guided Therapy Corporation | 2024-08-12 |
| 07540299000402 | PowerWire Pro Radiofrequency Guidewire Kit | Baylis Medical Technologies Inc | 2024-03-18 |
| 00856492005319 | WINGMAN14C | REFLOW MEDICAL, INC. | 2017-09-20 |
| 00856492005302 | WINGMAN14C | REFLOW MEDICAL, INC. | 2017-09-20 |
| 00856492005296 | WINGMAN14C | REFLOW MEDICAL, INC. | 2017-09-20 |
| 08714729839309 | TruePath™ | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 00856492005166 | WINGMAN35 | REFLOW MEDICAL, INC. | 2016-09-23 |
| 00856492005258 | WINGMAN18 | REFLOW MEDICAL, INC. | 2016-09-23 |
| 00856492005241 | WINGMAN18 | REFLOW MEDICAL, INC. | 2016-09-23 |
| 00856492005234 | WINGMAN18 | REFLOW MEDICAL, INC. | 2016-09-23 |
| 00856492005197 | WINGMAN14 | REFLOW MEDICAL, INC. | 2016-09-23 |
| 00856492005180 | WINGMAN35 | REFLOW MEDICAL, INC. | 2016-09-23 |
| 00856492005173 | WINGMAN35 | REFLOW MEDICAL, INC. | 2016-09-23 |
| 00856492005159 | WINGMAN14 | REFLOW MEDICAL, INC. | 2016-09-23 |
| 00856492005142 | WINGMAN14 | REFLOW MEDICAL, INC. | 2016-09-23 |
| 10801741125659 | CROSSER® | Bard Peripheral Vascular, Inc. | 2016-09-13 |
| 10801741125642 | CROSSER® | Bard Peripheral Vascular, Inc. | 2016-09-13 |
| 10801741125635 | CROSSER® | Bard Peripheral Vascular, Inc. | 2016-09-13 |
| 10801741125611 | CROSSER® | Bard Peripheral Vascular, Inc. | 2016-09-13 |
| 10801741125598 | CROSSER® | Bard Peripheral Vascular, Inc. | 2016-09-13 |
| 10801741125567 | CROSSER® | Bard Peripheral Vascular, Inc. | 2016-09-13 |
| 00845225002565 | Pioneer Plus Catheter | Philips Image Guided Therapy Corporation | 2016-09-01 |
| 00813132020286 | Turbo-Booster™ | Spectranetics Corporation | 2015-02-06 |
| 00813132020279 | Turbo-Booster™ | Spectranetics Corporation | 2015-02-06 |
| M2045180630 | Turbo-Booster™ | Spectranetics Corporation | 2014-09-15 |
| M2045180430 | Turbo-Booster™ | Spectranetics Corporation | 2014-09-15 |