510(k) K803270 ยท DQO Catheter, Intravascular, Diagnostic
GANZ CORONARY REPERFUSION CATHETER
| Applicant | American Edwards Laboratories, Mchenry IL, US |
| Decision | Substantially Equivalent, Mar 27, 1981 |
| Received | Dec 29, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K803270
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.