The following data is part of a premarket notification filed by Fresenius Usa, Inc. with the FDA for C.a.t.s Continuous Autotransfusion System Model 900500 1, At1 Autotransfusion Set Model 900 510 1, Psq Set (dd) Model 61.
| Device ID | K973378 |
| 510k Number | K973378 |
| Device Name: | C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM MODEL 900500 1, AT1 AUTOTRANSFUSION SET MODEL 900 510 1, PSQ SET (DD) MODEL 61 |
| Classification | Apparatus, Autotransfusion |
| Applicant | FRESENIUS USA, INC. 2637 SHADELANDS DR. Walnut Creek, CA 94598 |
| Contact | Virginia Singer |
| Correspondent | Virginia Singer FRESENIUS USA, INC. 2637 SHADELANDS DR. Walnut Creek, CA 94598 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-08 |
| Decision Date | 1997-11-03 |
| Summary: | summary |