AUTOTRANSFUSION SUCTION RESERVOIR WITH FILTER— 510(k) K940678

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K940678 for AUTOTRANSFUSION SUCTION RESERVOIR WITH FILTER, Substantially Equivalent on 1994-04-15. Applicant: Baxter Healthcare Corp.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code CAC
Advisory panel: Anesthesiology
Date received: 1994-02-09
Decision date: 1994-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, 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.