C.A.T.S. CONTINUOUS AUTOTRANSFUSION SYSTEM
FDA 510(k) clearance K960006 · decided 1996-07-31
Clearance details
- K-number
- K960006
- Device name
- C.A.T.S. CONTINUOUS AUTOTRANSFUSION SYSTEM
- Applicant
- Fresenius AG
- Decision
- Substantially Equivalent
- Date received
- 1996-01-02
- Decision date
- 1996-07-31
- Days to decision
- 211 days
- Clearance type
- Traditional
- Product code
- CAC
- Device class
- 2
- Regulation number
- 868.5830
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Foster, RI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| The box label states: "AT1 Autotransfusion Set 9005101 STERILE...FRESENIUS KABI...Freseniu recall (Z-0340-2011) | Fresenius Kabi, LLC | 2010-11-10 |
| The box label states: "ATF 40 Fast Start Kit 9108491...STERILE...FRESENIUS KABI...Freseniu recall (Z-0341-2011) | Fresenius Kabi, LLC | 2010-11-10 |
| The box label states: "ATF 120 Fast Start Kit 9108501...STERILE...FRESENIUS KABI...Freseni recall (Z-0342-2011) | Fresenius Kabi, LLC | 2010-11-10 |
| 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 |