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

Name: FDA 510(k) clearance K971274
Creator: U.S. Food and Drug Administration
Published: 1997-06-13

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. Device class: 2.

Clearance details

Applicant: Fresenius AG
Product code: Code CAC
Device class: Class 2
Regulation: 21 CFR 868.5830
Advisory panel: Anesthesiology
Date received: 1997-04-07
Decision date: 1997-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Foster, RI, US

Download summary PDF View on FDA.gov ↗

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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.