510(k) K971421 ยท DWA Control, Pump Speed, Cardiopulmonary Bypass
BARD ISOFLOW BLOOD PUMP
| Applicant | C.R. Bard, Inc., Haverhill MA, US |
| Decision | Substantially Equivalent, May 14, 1998 |
| Received | Apr 16, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971421
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.