PDU — Catheter For Crossing Total Occlusions Class II
Classification Details
- Product Code
- PDU
- Device Class
- Class II
- Regulation Number
- 870.1250
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252315 | angiosafe | Santreva-ATK Endovascular Revasculariztion Catheter | September 22, 2025 |
| K251158 | baylis medical technologies | PowerWire® 14 Radiofrequency Guidewire Kit | September 11, 2025 |
| K251376 | limflow | LimFlow ARC | May 31, 2025 |
| K232562 | baylis medical technologies | PowerWire Radiofrequency Guidewire Kit | February 28, 2024 |
| K230159 | soundbite medical solutions | SoundBite® Crossing System XS Peripheral | August 28, 2023 |
| K230594 | avinger | Tigereye ST CTO-Crossing Catheter | April 25, 2023 |
| K221163 | tractus vascular | Tunnel Crossing Catheter | January 19, 2023 |
| K221541 | limflow | LimFlow ARC | August 31, 2022 |
| K220544 | ra medical systems | DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2. | June 29, 2022 |
| K211802 | upstream peripheral technologies | GoBack Crossing Catheter | March 1, 2022 |
| K212468 | avinger | Tigereye CTO-Crossing Catheter | January 6, 2022 |
| K203363 | c.r. bard | Crosser iQ CTO Recanalization System | August 12, 2021 |
| K210664 | ra medical systems | DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101) | July 27, 2021 |
| K210839 | soundbite medical solutions | SoundBite Crossing System - Peripheral (14P) | April 20, 2021 |
| K201330 | avinger | Tigereye CTO-Crossing Catheter | September 10, 2020 |
| K192211 | soundbite medical solution | SoundBite Console, SoundBite Active Wire 18 | January 17, 2020 |
| K183357 | xablecath | XableCath Crossing Catheter | January 21, 2019 |
| K170349 | ra medical systems | RA-308 Excimer Laser System, Excimer Laser Catheter | May 24, 2017 |
| K162418 | philips volcano | Pioneer Plus Catheter | December 2, 2016 |
| K161208 | bard peripheral vacular | CROSSER CTO Recanalization Catheter | May 24, 2016 |