BRAT 2 AUTOLOGUS BLOOD SALVAGE SYSTEM
FDA 510(k) clearance K933625 · decided 1993-12-29
Clearance details
- K-number
- K933625
- Device name
- BRAT 2 AUTOLOGUS BLOOD SALVAGE SYSTEM
- Applicant
- Cobe Cardiovascular, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-07-19
- Decision date
- 1993-12-29
- Days to decision
- 163 days
- Clearance type
- Traditional
- Product code
- CAC
- Device class
- 2
- Regulation number
- 868.5830
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Arvada, CO, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Cobe Cardiovascular
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ASY Brat 2 Procedure Set, for blood recovery & autotransfusion. recall (Z-1069-05) | Cobe Cardiovascular, Inc | 2005-08-03 |
| ASY, Brat 2 Pack Procedure Set recall (Z-1070-05) | Cobe Cardiovascular, Inc | 2005-08-03 |
| ASY Brat 2 Procedure Set recall (Z-1071-05) | Cobe Cardiovascular, Inc | 2005-08-03 |
| ASY, Brat Pack Procedure Set recall (Z-1072-05) | Cobe Cardiovascular, Inc | 2005-08-03 |
| ASY Brat 2 Procedure Set recall (Z-1073-05) | Cobe Cardiovascular, Inc | 2005-08-03 |
| ASY, Brat 2 Procedure Set recall (Z-1074-05) | Cobe Cardiovascular, Inc | 2005-08-03 |