510(k) K860497 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
CAROTID BALLOON SHUNT
| Applicant | Imodex, Inc., St. Clair Shores MI, US |
| Decision | Substantially Equivalent, May 28, 1986 |
| Received | Feb 10, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K860497
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.