The following data is part of a premarket notification filed by Fresenius Ag with the FDA for C.a.t.s Continuous Autotransfusion System, At1 Autotransfusion Set, Psq Set.
| Device ID | K971274 |
| 510k Number | K971274 |
| Device Name: | C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM, AT1 AUTOTRANSFUSION SET, PSQ SET |
| 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 | 1997-04-07 |
| Decision Date | 1997-06-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04052682000478 | K971274 | 000 |