PDU · Catheter For Crossing Total Occlusions
Cardiovascular · 21 CFR 870.1250 · Class 2
Overview
| Product Code | PDU |
|---|---|
| Device Name | Catheter For Crossing Total Occlusions |
| Regulation | 21 CFR 870.1250 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
Identification
A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 57)
Showing 20 most recent of 57 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252315 | Santreva-ATK Endovascular Revasculariztion Catheter | AngioSafe, Inc. | Sep 22, 2025 | SESE |
| K251158 | PowerWire® 14 Radiofrequency Guidewire Kit | Baylis Medical Technologies, Inc. | Sep 11, 2025 | SESK |
| K251376 | LimFlow ARC | LimFlow, Inc. | May 31, 2025 | SESE |
| K232562 | PowerWire Radiofrequency Guidewire Kit | Baylis Medical Technologies, Inc. | Feb 28, 2024 | SESK |
| K230159 | SoundBite® Crossing System XS Peripheral | Soundbite Medical Solutions, Inc. | Aug 28, 2023 | SESE |
| K230594 | Tigereye ST CTO-Crossing Catheter | Avinger, Inc. | Apr 25, 2023 | SESE |
| K221163 | Tunnel Crossing Catheter | Tractus Vascular, LLC | Jan 19, 2023 | SESE |
| K221541 | LimFlow ARC | LimFlow, Inc. | Aug 31, 2022 | SESE |
| K220544 | DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0) | Ra Medical Systems,Inc | Jun 29, 2022 | SESE |
| K211802 | GoBack Crossing Catheter | Upstream Peripheral Technologies, Ltd. | Mar 1, 2022 | SESE |
| K212468 | Tigereye CTO-Crossing Catheter | Avinger, Inc. | Jan 6, 2022 | SESE |
| K203363 | Crosser iQ CTO Recanalization System | C.R. Bard, Inc. | Aug 12, 2021 | SESE |
| K210664 | DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101) | Ra Medical Systems,Inc | Jul 27, 2021 | SESE |
| K210839 | SoundBite Crossing System - Peripheral (14P) | Soundbite Medical Solutions, Inc. | Apr 20, 2021 | SESE |
| K201330 | Tigereye CTO-Crossing Catheter | Avinger, Inc. | Sep 10, 2020 | SESE |
| K192211 | SoundBite Console, SoundBite Active Wire 18 | Soundbite Medical Solution, Inc. | Jan 17, 2020 | SESE |
| K183357 | XableCath Crossing Catheter | Xablecath, Inc. | Jan 21, 2019 | SESE |
| K170349 | RA-308 Excimer Laser System, Excimer Laser Catheter | Ra Medical Systems,Inc | May 24, 2017 | SESE |
| K162418 | Pioneer Plus Catheter | Philips Volcano | Dec 2, 2016 | SESE |
| K161208 | CROSSER CTO Recanalization Catheter | Bard Peripheral Vacular, Inc. | May 24, 2016 | SESE |
Top Applicants
- Avinger, Inc. — 10 clearances
- Spectranetics Corp. — 7 clearances
- Flowcardia, Inc. — 3 clearances
- Lumend, Inc. — 3 clearances
- Ra Medical Systems,Inc — 3 clearances
