510(k) K913477 ยท KOE Dilator, Urethral
APEX(TM) PROSTATIC BALLOON DILATION CATHETER
| Applicant | Peripheral Systems Group, Mountain View CA, US |
| Decision | Substantially Equivalent, Dec 27, 1991 |
| Received | Aug 5, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913477
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.