TUBING CONNECTORS EC-2XXX SERIES— 510(k) K833322

Substantially Equivalent

Gish Biomedical, Inc.

FDA 510(k) clearance K833322 for TUBING CONNECTORS EC-2XXX SERIES, Substantially Equivalent on 1983-12-16. Applicant: Gish Biomedical, Inc..

Clearance details

Applicant: Gish Biomedical, Inc.
Product code: Code DTL
Advisory panel: Cardiovascular
Date received: 1983-09-26
Decision date: 1983-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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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.