FILTER PURGE LINE EC-FPL SERIES— 510(k) K833644

Substantially Equivalent

Gish Biomedical, Inc.

FDA 510(k) clearance K833644 for FILTER PURGE LINE EC-FPL SERIES, Substantially Equivalent on 1984-12-29. Applicant: Gish Biomedical, Inc..

Clearance details

Applicant: Gish Biomedical, Inc.
Product code: Code DTL
Advisory panel: Cardiovascular
Date received: 1983-10-17
Decision date: 1984-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DTL

product code DTL

Malfunction: 770
Total: 770

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.