510(k) K915363 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
SARNS 7850 CENTRIFUGAL PUMP (MODIFIED)
| Applicant | 3M Health Care, Ltd., Ann Arbor MI, US |
| Decision | Substantially Equivalent, Jul 28, 1993 |
| Received | Nov 27, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915363
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 17, 2009 | Terumo Cardiovascular Systems Corporation Sarns Centrifugal Pump (without X-coating), catalog 164275, packaged in 8 piece shelf boxes, and convenience kits with single pump units.
Indicated as extracorporeal blood pumps for use in cardiopulm Terminated |
KFM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.