MEDICAL ASSEMBLIES FILTER— 510(k) K911738

Substantially Equivalent

Medical Assemblies, Inc.

FDA 510(k) clearance K911738 for MEDICAL ASSEMBLIES FILTER, Substantially Equivalent on 1991-07-11. Applicant: Medical Assemblies, Inc..

Clearance details

Applicant: Medical Assemblies, Inc.
Product code: Code CAH
Advisory panel: Anesthesiology
Date received: 1991-04-17
Decision date: 1991-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, IN, 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.