510(k) K113681 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
GLADIATOR PTA BALLOON DILATION CATHETER
| Applicant | Boston Scientific, Maple Grove MN, US |
| Decision | Substantially Equivalent, Jan 11, 2012 |
| Received | Dec 15, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K113681
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.