K213728 is an FDA 510(k) clearance for the Serranator PTA Serration Balloon Catheter. This device is classified as a Catheter, Percutaneous, Cutting/scoring (Class II - Special Controls, product code PNO).
Submitted by Cagent Vascular, LLC (Wayne, US). The FDA issued a Cleared decision on December 15, 2021, 19 days after receiving the submission on November 26, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250. To Reduce Vascular Stenosis By Dilatation And Apposition Of The Cutting/scoring Surfaces To The Stenotic Material.
| 510(k) Number | K213728 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 26, 2021 |
| Decision Date | December 15, 2021 |
| Days to Decision | 19 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | PNO - Catheter, Percutaneous, Cutting/scoring |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |
| Definition | To Reduce Vascular Stenosis By Dilatation And Apposition Of The Cutting/scoring Surfaces To The Stenotic Material |