SARN CENTRIFUGAL PUMP
FDA 510(k) clearance K112229 · decided 2011-12-09
Clearance details
- K-number
- K112229
- Device name
- SARN CENTRIFUGAL PUMP
- Applicant
- Terumo Cardiovascular Systems
- Decision
- Substantially Equivalent
- Date received
- 2011-08-03
- Decision date
- 2011-12-09
- Days to decision
- 128 days
- Clearance type
- Traditional
- Product code
- KFM
- Device class
- 2
- Regulation number
- 870.4360
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Ann Arbor, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| The Sarns Centrifugal Pump is a single use device sterilized by ethylene oxide gas. The de recall (Z-1235-2017) | Terumo Cardiovascular Systems Corporation | 2017-02-22 |
| Sarns Disposable Centrifugal Pump without X-Coating,164275, is a sterile, single use devic recall (Z-2028-2014) | Terumo Cardiovascular Systems Corporation | 2014-07-11 |
| Sarns Disposable Centrifugal Pump with X-Coating, 164275X, is a sterile, single use device recall (Z-2029-2014) | Terumo Cardiovascular Systems Corporation | 2014-07-11 |
| Cardiovascular Procedure Kit containing Disposable Centrifugal Pumphead with or without X- recall (Z-2030-2014) | Terumo Cardiovascular Systems Corporation | 2014-07-11 |