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 The Crit-line Hematocrit Sampling System Option.
| Device ID | K991986 |
| 510k Number | K991986 |
| Device Name: | COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH THE CRIT-LINE HEMATOCRIT SAMPLING SYSTEM OPTION |
| 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 | 1999-06-14 |
| Decision Date | 1999-09-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10803622133067 | K991986 | 000 |
| 10803622132206 | K991986 | 000 |
| 10803622132213 | K991986 | 000 |
| 10803622132220 | K991986 | 000 |
| 10803622132237 | K991986 | 000 |
| 10803622132244 | K991986 | 000 |
| 10803622132251 | K991986 | 000 |
| 10803622132268 | K991986 | 000 |
| 10803622132275 | K991986 | 000 |
| 10803622132282 | K991986 | 000 |
| 10803622132299 | K991986 | 000 |
| 10803622132305 | K991986 | 000 |
| 10803622132312 | K991986 | 000 |
| 10803622123136 | K991986 | 000 |