510(k) K163380 ยท PNO Catheter, Percutaneous, Cutting/Scoring
Serranator Alto PTA Serration Balloon Catheter
| Applicant | Cagent Vascular, LLC, Wayne PA, US |
| Decision | Substantially Equivalent, Feb 13, 2017 |
| Received | Dec 1, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163380
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.