DAVOL AUTOTRANSFUSION BLOOD PROCESSING SYSTEM— 510(k) K901401

Substantially Equivalent

Davol, Inc.

FDA 510(k) clearance K901401 for DAVOL AUTOTRANSFUSION BLOOD PROCESSING SYSTEM, Substantially Equivalent on 1990-10-23. Applicant: Davol, Inc..

Clearance details

Applicant: Davol, Inc.
Product code: Code CAC
Advisory panel: Anesthesiology
Date received: 1990-03-26
Decision date: 1990-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cranston, 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.