K230594 is an FDA 510(k) clearance for the Tigereye ST CTO-Crossing Catheter. This device is classified as a Catheter For Crossing Total Occlusions (Class II - Special Controls, product code PDU).
Submitted by Avinger, Inc. (Redwood City, US). The FDA issued a Cleared decision on April 25, 2023, 53 days after receiving the submission on March 3, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250. 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..
| 510(k) Number | K230594 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 03, 2023 |
| Decision Date | April 25, 2023 |
| Days to Decision | 53 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | PDU — Catheter For Crossing Total Occlusions |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |
| Definition | 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. |