Ocelot Pixl Catheter
FDA 510(k) K123532 · Avinger, Inc.
510(k) numberK123532
Submission
- Device name
- Ocelot Pixl Catheter
- Applicant
- Avinger, Inc.
Redwood City, CA, US - Received
- November 16, 2012
- Decision date
- December 14, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| K252315 | Santreva-ATK Endovascular Revasculariztion CatheterPDU · Traditional | AngioSafe, Inc. | 09/22/2025SE |
| 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 |
More from Ra Medical Systems,Inc
| 510(k) | Device | Decision |
|---|---|---|
| K230005 | Pantheris LV Atherectomy CatheterMCW · Traditional | 06/06/2023SE |
| K230594 | Tigereye ST CTO-Crossing CatheterPDU · Traditional | 04/25/2023SE |
| K212468 | Tigereye CTO-Crossing CatheterPDU · Traditional | 01/06/2022SE |
| K212047 | Pantheris SystemMCW · Traditional | 11/16/2021SE |
| K201330 | Tigereye CTO-Crossing CatheterPDU · Traditional | 09/10/2020SE |
| K182341 | Pantheris SVMCW · Traditional | 04/09/2019SE |
| K173862 | Pantheris SystemMCW · Traditional | 05/22/2018SE |
| K172236 | Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox…MCW · Special | 10/30/2017SE |
| K163264 | Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox SledMCW · Special | 12/21/2016SE |
| K162326 | Pantheris Catheter, Lightbix HS Imaging Console, Lightbox SledMCW · Traditional | 10/18/2016SE |
Questions and answers
When was Ocelot Pixl Catheter cleared by the FDA?
Ocelot Pixl Catheter (K123532) received a 510(k) decision of Substantially Equivalent on December 14, 2012, 28 days after the submission was received.
What is the product code of K123532?
The FDA product code is PDU – Catheter For Crossing Total Occlusions, a Class II (moderate risk) device regulated under 21 CFR 870.1250.