The following data is part of a premarket notification filed by Cobe Cardiovascular, Inc. with the FDA for Cobe Brat 2 Autologous Blood Salvage System With Modified Plasma Recovery Program (prp).
| Device ID | K962689 |
| 510k Number | K962689 |
| Device Name: | COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH MODIFIED PLASMA RECOVERY PROGRAM (PRP) |
| 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 | 1996-07-11 |
| Decision Date | 1997-01-28 |
| Summary: | summary |