MINI-OP ATS BLOOD RECOVERY BAG, MOEL 2950— 510(k) K912609

Substantially Equivalent

Atrium Medical Corp.

FDA 510(k) clearance K912609 for MINI-OP ATS BLOOD RECOVERY BAG, MOEL 2950, Substantially Equivalent on 1991-11-29. Applicant: Atrium Medical Corp..

Clearance details

Applicant: Atrium Medical Corp.
Product code: Code CAC
Advisory panel: Anesthesiology
Date received: 1991-06-12
Decision date: 1991-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hollis, NH, 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.