Santreva-ATK Endovascular Revasculariztion Catheter
FDA 510(k) K252315 · AngioSafe, Inc.
510(k) numberK252315
Submission
- Device name
- Santreva-ATK Endovascular Revasculariztion Catheter
- Applicant
- AngioSafe, Inc.
San Jose, CA, US - Received
- July 25, 2025
- Decision date
- September 22, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PDU – Catheter For Crossing Total Occlusions
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
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.
Other 510(k)s with product code PDU
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262013 | Kiba CTO Crossing CatheterPDU · Special | Reflow Medical, Inc. | 08/28/2026SE |
| K251158 | PowerWire® 14 Radiofrequency Guidewire KitPDU · Traditional | Baylis Medical Technologies, Inc. | 09/11/2025SESK |
| K251376 | LimFlow ARCPDU · Special | LimFlow, Inc. | 05/31/2025SE |
| K232562 | PowerWire Radiofrequency Guidewire KitPDU · Traditional | Baylis Medical Technologies, Inc. | 02/28/2024SESK |
| K230159 | SoundBite® Crossing System XS PeripheralPDU · Traditional | Soundbite Medical Solutions, Inc. | 08/28/2023SE |
| K230594 | Tigereye ST CTO-Crossing CatheterPDU · Traditional | Avinger, Inc. | 04/25/2023SE |
| K221163 | Tunnel Crossing CatheterPDU · Traditional | Tractus Vascular, LLC | 01/19/2023SE |
| K221541 | LimFlow ARCPDU · Traditional | LimFlow, Inc. | 08/31/2022SE |
| K220544 | DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)PDU · Traditional | Ra Medical Systems,Inc | 06/29/2022SE |
| K211802 | GoBack Crossing CatheterPDU · Traditional | Upstream Peripheral Technologies, Ltd. | 03/01/2022SE |
Questions and answers
When was Santreva-ATK Endovascular Revasculariztion Catheter cleared by the FDA?
Santreva-ATK Endovascular Revasculariztion Catheter (K252315) received a 510(k) decision of Substantially Equivalent on September 22, 2025, 59 days after the submission was received.
What is the product code of K252315?
The FDA product code is PDU – Catheter For Crossing Total Occlusions, a Class II (moderate risk) device regulated under 21 CFR 870.1250.