510(k) K861428 ยท DWD Suction Control, Intracardiac, Cardiopulmonary Bypass
SUCTION CONTROL VALVE (NONADJUSTABLE) CAT.RLV-2100
| Applicant | American Omni Medical, Inc., Costa Mesa CA, US |
| Decision | Substantially Equivalent, Jun 26, 1986 |
| Received | Apr 16, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K861428
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.