GISH TUBING AND CONNECTORS WITH GBS COATING— 510(k) K030077

Substantially Equivalent

Gish Biomedical, Inc.

FDA 510(k) clearance K030077 for GISH TUBING AND CONNECTORS WITH GBS COATING, Substantially Equivalent on 2003-03-14. Applicant: Gish Biomedical, Inc..

Clearance details

Applicant: Gish Biomedical, Inc.
Product code: Code DTL
Advisory panel: Cardiovascular
Date received: 2003-01-08
Decision date: 2003-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, 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.