510(k) K882758 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
CENTRIFUGAL PUMP SYSTEM LX/DX VERSION
| Applicant | 3M Health Care, Sarns, Ann Arbor MI, US |
| Decision | Substantially Equivalent, Oct 13, 1988 |
| Received | Jul 5, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K882758
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 11, 2012 | Terumo Cardiovascular Systems Corporation Sarns Centrifugal System Control module, 100/115V
The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only. Terminated |
KFM | None listed |
| Oct 11, 2012 | Terumo Cardiovascular Systems Corporation Sarns Centrifugal System Control module, 220/240V
The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only. Terminated |
KFM | None listed |
| Oct 11, 2012 | Terumo Cardiovascular Systems Corporation Sarns Centrifugal System Control module System 9000
The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only. Terminated |
KFM | None listed |
| Oct 11, 2012 | Terumo Cardiovascular Systems Corporation Battery, 100/115V (Includes charger and connecting cable)
The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass procedures only. Terminated |
KFM | None listed |
| Oct 11, 2012 | Terumo Cardiovascular Systems Corporation Battery, 220V (Includes charger and connecting cable)
The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass procedures only. Terminated |
KFM | None listed |
| Mar 14, 2007 | Terumo Cardiovascular Systems Corp Manual Drive Unit for Sarns (Terumo) Centrifugal Perfusion System; Catalog No. 164268. Terminated |
KFM | None listed |
| Dec 7, 2006 | Terumo Cardiovascular Systems Corp Manual Drive Unit for Sarns (Terumo) Centrifugal Perfusion System; Catalog No. 164268. Terminated |
DTW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.