510(k) K963688 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
FOCUS PV BALLOON DILATATION CATHETER
| Applicant | Cardiovascular Dynamics, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Mar 28, 1997 |
| Received | Sep 16, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963688
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.