COBE BRAT 2 SYSTEM WITH MODIFIED STANDARD VOLUME PROCESSING SET— 510(k) K974897

Substantially Equivalent

Cobe Cardiovascular, Inc.

FDA 510(k) clearance K974897 for COBE BRAT 2 SYSTEM WITH MODIFIED STANDARD VOLUME PROCESSING SET, Substantially Equivalent on 1998-03-31. Applicant: Cobe Cardiovascular, Inc..

Clearance details

Applicant: Cobe Cardiovascular, Inc.
Product code: Code CAC
Advisory panel: Anesthesiology
Date received: 1997-12-31
Decision date: 1998-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arvada, CO, US

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Adverse events under product code CAC

product code CAC

Death: 11
Malfunction: 477
Total: 488

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.