510(k) K971577 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
FOCUS-PV BALLOON DILATATION CATHETER
| Applicant | Cardiovascular Dynamics, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Jun 18, 1997 |
| Received | Apr 21, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971577
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.