ANTEGRADE/RETROGRADE CARDIOPLEGIA VALVE SYSTEMS— 510(k) K922840

Substantially Equivalent

Gish Biomedical, Inc.

FDA 510(k) clearance K922840 for ANTEGRADE/RETROGRADE CARDIOPLEGIA VALVE SYSTEMS, Substantially Equivalent on 1993-05-17. Applicant: Gish Biomedical, Inc..

Clearance details

Applicant: Gish Biomedical, Inc.
Product code: Code DTL
Advisory panel: Cardiovascular
Date received: 1992-06-12
Decision date: 1993-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, 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.