The following data is part of a premarket notification filed by Fresenius Ag with the FDA for C.a.t.s. Continuous Autotransfusion System.
| Device ID | K960006 |
| 510k Number | K960006 |
| Device Name: | C.A.T.S. CONTINUOUS AUTOTRANSFUSION SYSTEM |
| Classification | Apparatus, Autotransfusion |
| Applicant | FRESENIUS AG 53 KENNEDY RD. Foster, RI 02825 |
| Contact | Annette M Fagnant |
| Correspondent | Annette M Fagnant FRESENIUS AG 53 KENNEDY RD. Foster, RI 02825 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-02 |
| Decision Date | 1996-07-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04086000860031 | K960006 | 000 |
| 04052682000706 | K960006 | 000 |
| 04052682000683 | K960006 | 000 |
| 04052682000614 | K960006 | 000 |
| 04052682000591 | K960006 | 000 |
| 04052682000454 | K960006 | 000 |