510(k) K850790 ยท KOD Catheter, Urological
DIAFLEX OCCLUSION BALLOON CATHETER
| Applicant | American Edwards Laboratories, Santa Ana CA, US |
| Decision | Substantially Equivalent, Mar 25, 1985 |
| Received | Feb 26, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K850790
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.