510(k) K963335 ยท DQO Catheter, Intravascular, Diagnostic
HARMAC BALLOON WEDGE PRESSURE CATHETER
| Applicant | Harmac Medical Products, Inc., Buffalo NY, US |
| Decision | Substantially Equivalent, Oct 16, 1997 |
| Received | Jun 28, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963335
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.