510(k) K954313 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
FOCUS PC BALLOON DILATATION CATHETER
| Applicant | Cardio-Dynamics, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Dec 1, 1995 |
| Received | Sep 15, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954313
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.