510(k) K193181 ยท PNO Catheter, Percutaneous, Cutting/Scoring
Serranator PTA Serration Balloon Catheter
| Applicant | Cagent Vascular, LLC, Wayne PA, US |
| Decision | Substantially Equivalent, Apr 15, 2020 |
| Received | Nov 18, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193181
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.