510(k) K112229 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
SARN CENTRIFUGAL PUMP
| Applicant | Terumo Cardiovascular Systems, Ann Arbor MI, US |
| Decision | Substantially Equivalent, Dec 9, 2011 |
| Received | Aug 3, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112229
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 22, 2017 | Terumo Cardiovascular Systems Corporation The Sarns Centrifugal Pump is a single use device sterilized by ethylene oxide gas. The device is sold single sterile in cartons of 8 units, or may be provided in bulk, non-sterile to another Teru Terminated |
KFM | None listed |
| Jul 11, 2014 | Terumo Cardiovascular Systems Corporation Sarns Disposable Centrifugal Pump without X-Coating,164275, is a sterile, single use device.
For use in cardiopulmonary bypass procedures. Terminated |
KFM | None listed |
| Jul 11, 2014 | Terumo Cardiovascular Systems Corporation Sarns Disposable Centrifugal Pump with X-Coating, 164275X, is a sterile, single use device.
For use in cardiopulmonary bypass procedures. Terminated |
KFM | None listed |
| Jul 11, 2014 | Terumo Cardiovascular Systems Corporation Cardiovascular Procedure Kit containing Disposable Centrifugal Pumphead with or without X-Coating, sterile single use.
Catalog numbers
73431, 73813-03, 74277, 72481-01, 72427, 70947-03, 74570-01, 7 Terminated |
KFM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.