510(k) K132810 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
GLADIATOR ELITE PTA BALLOON DILATATION CATHETER
| Applicant | Boston Scientific Corp, Maple Grove MN, US |
| Decision | Substantially Equivalent, Feb 28, 2014 |
| Received | Sep 9, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132810
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.