510(k) K944016 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
FOCUS BALLOON DILATATION CATHETER
| Applicant | Cardiovascular Dynamics, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Dec 20, 1994 |
| Received | Aug 16, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K944016
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.