510(k) K001134 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
GAZELLE BALLOON DILATATION CATHETER
| Applicant | Boston Scientific Corp, Natick, MA, US |
| Decision | Substantially Equivalent, Aug 31, 2000 |
| Received | Apr 10, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001134
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.