Tigereye ST CTO-Crossing Catheter
FDA 510(k) K230594 · Avinger, Inc.
510(k) numberK230594
Submission
- Device name
- Tigereye ST CTO-Crossing Catheter
- Applicant
- Avinger, Inc.
Redwood City, CA, US - Received
- March 3, 2023
- Decision date
- April 25, 2023
- 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.
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| 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 |
| 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 |
More from Upstream Peripheral Technologies, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K230005 | Pantheris LV Atherectomy CatheterMCW · Traditional | 06/06/2023SE |
| 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 |
| K160827 | Pantheris CatheterMCW · Special | 04/21/2016SE |
Questions and answers
When was Tigereye ST CTO-Crossing Catheter cleared by the FDA?
Tigereye ST CTO-Crossing Catheter (K230594) received a 510(k) decision of Substantially Equivalent on April 25, 2023, 53 days after the submission was received.
What is the product code of K230594?
The FDA product code is PDU – Catheter For Crossing Total Occlusions, a Class II (moderate risk) device regulated under 21 CFR 870.1250.