C.A.T.S. CONTINUOUS AUTOTRANSFUSION SYSTEM— 510(k) K960006

Substantially Equivalent

Fresenius AG

FDA 510(k) clearance K960006 for C.A.T.S. CONTINUOUS AUTOTRANSFUSION SYSTEM, Substantially Equivalent on 1996-07-31. Applicant: Fresenius AG.

Clearance details

Applicant: Fresenius AG
Product code: Code CAC
Advisory panel: Anesthesiology
Date received: 1996-01-02
Decision date: 1996-07-31
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.