FRESENIUS C.A.T.S; ATI AUTOTRANSFUSION SET; PSQ PLASMA SEQUESTRATION SET; PSQ-DD PLASMA SEQUESTRATION DIRECT DRAW
FDA 510(k) clearance K012178 · decided 2001-07-23
Clearance details
- K-number
- K012178
- Device name
- FRESENIUS C.A.T.S; ATI AUTOTRANSFUSION SET; PSQ PLASMA SEQUESTRATION SET; PSQ-DD PLASMA SEQUESTRATION DIRECT DRAW
- Applicant
- Fresenius Hemotechnology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-07-12
- Decision date
- 2001-07-23
- Days to decision
- 11 days
- Clearance type
- Special
- Product code
- CAC
- Device class
- 2
- Regulation number
- 868.5830
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Redmond, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ATF 40 Fast Start Kit - contains one each AT1 Autotransfusion Set, ATS Suction Line, and t recall (Z-0906-03) | Fresenius Hemocare, Inc. | 2003-06-05 |