510(k) K813035 ยท DWB Pump, Blood, Cardiopulmonary Bypass, Roller Type
POLYSTAN VERTICLUDE BLOOD PUMP
| Applicant | Advocacy International, Ltd., Walker MI, US |
| Decision | Substantially Equivalent, Nov 27, 1981 |
| Received | Oct 28, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K813035
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.