FILTER-FLEX— 510(k) K841236

Substantially Equivalent

Life Design Systems, Inc.

FDA 510(k) clearance K841236 for FILTER-FLEX, Substantially Equivalent on 1984-04-05. Applicant: Life Design Systems, Inc..

Clearance details

Applicant: Life Design Systems, Inc.
Product code: Code CAH
Advisory panel: Anesthesiology
Date received: 1984-03-22
Decision date: 1984-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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.