The following data is part of a premarket notification filed by Cobe Cardiovascular, Inc. with the FDA for Cobe Brat 2 System With Modified Standard Volume Processing Set.
| Device ID | K974897 |
| 510k Number | K974897 |
| Device Name: | COBE BRAT 2 SYSTEM WITH MODIFIED STANDARD VOLUME PROCESSING SET |
| Classification | Apparatus, Autotransfusion |
| Applicant | COBE CARDIOVASCULAR, INC. 14401 WEST 65TH WAY Arvada, CO 80004 |
| Contact | Lynne Leonard |
| Correspondent | Lynne Leonard COBE CARDIOVASCULAR, INC. 14401 WEST 65TH WAY Arvada, CO 80004 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-31 |
| Decision Date | 1998-03-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 38033178109728 | K974897 | 000 |
| 38033178109711 | K974897 | 000 |
| 38033178106055 | K974897 | 000 |
| 38033178106048 | K974897 | 000 |
| 38033178106017 | K974897 | 000 |
| 38033178106000 | K974897 | 000 |
| 38033178105980 | K974897 | 000 |
| 38033178105973 | K974897 | 000 |