SARNS CENTRIFUGAL PUMP WITH XCOATING, MODEL 164275X
FDA 510(k) clearance K020998 · decided 2002-04-04
Clearance details
- K-number
- K020998
- Device name
- SARNS CENTRIFUGAL PUMP WITH XCOATING, MODEL 164275X
- Applicant
- Terumo Cardiovascular Systems Corp.
- Decision
- Substantially Equivalent
- Date received
- 2002-03-28
- Decision date
- 2002-04-04
- Days to decision
- 7 days
- Clearance type
- Special
- Product code
- KFM
- Device class
- 2
- Regulation number
- 870.4360
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Elkton, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Sarns Centrifugal Pump with X-Coating, packaged within custom ordered Cardiovascular Proce recall (Z-2606-2010) | Terumo Cardiovascular Corporation | 2010-09-28 |
| Sarns Centrifugal Pump (with X-coating), catalog 164275X, packaged in 8 piece shelf boxes, recall (Z-0544-2010) | Terumo Cardiovascular Systems Corporation | 2009-12-17 |