Tigereye CTO-Crossing Catheter
FDA 510(k) K212468 · Avinger, Inc.
510(k) numberK212468
Submission
- Device name
- Tigereye CTO-Crossing Catheter
- Applicant
- Avinger, Inc.
Redwood City, CA, US - Received
- August 6, 2021
- Decision date
- January 6, 2022
- 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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| K230159 | SoundBite® Crossing System XS PeripheralPDU · Traditional | Soundbite Medical Solutions, Inc. | 08/28/2023SE |
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| K221541 | LimFlow ARCPDU · Traditional | LimFlow, Inc. | 08/31/2022SE |
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| K230005 | Pantheris LV Atherectomy CatheterMCW · Traditional | 06/06/2023SE |
| K230594 | Tigereye ST CTO-Crossing CatheterPDU · Traditional | 04/25/2023SE |
| 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 CTO-Crossing Catheter cleared by the FDA?
Tigereye CTO-Crossing Catheter (K212468) received a 510(k) decision of Substantially Equivalent on January 6, 2022, 153 days after the submission was received.
What is the product code of K212468?
The FDA product code is PDU – Catheter For Crossing Total Occlusions, a Class II (moderate risk) device regulated under 21 CFR 870.1250.