510(k) K020998 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
SARNS CENTRIFUGAL PUMP WITH XCOATING, MODEL 164275X
| Applicant | Terumo Cardiovascular Systems Corp., Elkton MD, US |
| Decision | Substantially Equivalent, Apr 4, 2002 |
| Received | Mar 28, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K020998
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 28, 2010 | Terumo Cardiovascular Corporation Sarns Centrifugal Pump with X-Coating, packaged within custom ordered Cardiovascular Procedure Kits, P/N 3ZZ164275X, 3ZZ164275, CEOT028, CEOT032; and as single sterile units with product codes CV-1642 Terminated |
KFM | None listed |
| Dec 17, 2009 | Terumo Cardiovascular Systems Corporation Sarns Centrifugal Pump (with X-coating), catalog 164275X, packaged in 8 piece shelf boxes, and convenience kits with single pump units.
Indicated as extracorporeal blood pumps for use in cardiopulmon Terminated |
KFM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.