510(k) K142654 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
Fortrex 0.035 OTW PTA Balloon Catheter
| Applicant | Covidien, LLC, Plymouth MN, US |
| Decision | Substantially Equivalent, Oct 28, 2014 |
| Received | Sep 18, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142654
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.