K973378

Substantially Equivalent

C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM MODEL 900500 1, AT1 AUTOTRANSFUSION SET MODEL 900 510 1, PSQ SET (DD) MODEL 61

Applicant: Fresenius USA, Inc.
Product code: CAC
Advisory panel: Anesthesiology
Date received: 1997-09-08
Decision date: 1997-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walnut Creek, CA, 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.