WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)]— 510(k) K121382

Substantially Equivalent

Westmed, Inc.

FDA 510(k) clearance K121382 for WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)], Substantially Equivalent on 2012-12-06. Applicant: Westmed, Inc..

Clearance details

Applicant: Westmed, Inc.
Product code: Code CAH
Advisory panel: Anesthesiology
Date received: 2012-05-08
Decision date: 2012-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tucson, AZ, US

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Adverse events under product code CAH

product code CAH

Death: 7
Total: 7

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.