510(k) K972825 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
OPTA5 PTA BALLOON CATHETER, POWERFLEX PTA BALLOON CATHETER, ULTRA-THIN DIAMOND BALLOON CATHETER, PALMAZ BALLOON EXPANDAB
| Applicant | Cordis Corp., Miami Lakes FL, US |
| Decision | Substantially Equivalent, Oct 7, 1997 |
| Received | Jul 9, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972825
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.