The following data is part of a premarket notification filed by Cagent Vascular, Llc with the FDA for Serranator Alto Pta Serration Balloon Catheter.
| Device ID | K163380 |
| 510k Number | K163380 |
| Device Name: | Serranator Alto PTA Serration Balloon Catheter |
| Classification | Catheter, Percutaneous, Cutting/scoring |
| Applicant | Cagent Vascular, LLC 150 Strafford Avenue #315 Wayne, PA 19087 |
| Contact | Carol Burns |
| Correspondent | Carol Burns Cagent Vascular, LLC 150 Strafford Avenue #315 Wayne, PA 19087 |
| Product Code | PNO |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-01 |
| Decision Date | 2017-02-13 |
| Summary: | summary |