510(k) K941012 ยท EYB Catheter, Ureteral, Gastro-Urology
LOW PRESSURE TAMPONADE BALLOON CATHETER
| Applicant | Applied Medical Resources, Launa Hills CA, US |
| Decision | Substantially Equivalent, Apr 18, 1994 |
| Received | Mar 3, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K941012
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.