The following data is part of a premarket notification filed by Cobe Cardiovascular, Inc. with the FDA for Cobe Brat Systems Without Reinfusion Protection.
| Device ID | K913773 |
| 510k Number | K913773 |
| Device Name: | COBE BRAT SYSTEMS WITHOUT REINFUSION PROTECTION |
| Classification | Apparatus, Autotransfusion |
| Applicant | COBE CARDIOVASCULAR, INC. 14401 WEST 65TH WAY Arvada, CO 80004 |
| Contact | Mary L Armstrong |
| Correspondent | Mary L Armstrong 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 | 1991-08-23 |
| Decision Date | 1992-01-27 |