C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM, AT1 AUTOTRANSFUSION SET, PSQ SET— 510(k) K971274

Substantially Equivalent

Fresenius AG

FDA 510(k) clearance K971274 for C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM, AT1 AUTOTRANSFUSION SET, PSQ SET, Substantially Equivalent on 1997-06-13. Applicant: Fresenius AG.

Clearance details

Applicant: Fresenius AG
Product code: Code CAC
Advisory panel: Anesthesiology
Date received: 1997-04-07
Decision date: 1997-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Foster, RI, 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.