510(k) K882052 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
OMEGA NV(TM) BALLOON DILATATION CATHETER
| Applicant | Cook, Inc., Bloomington IN, US |
| Decision | Substantially Equivalent, Sep 14, 1988 |
| Received | May 16, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K882052
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.