GISH VISION BLOOD CARDIOPLEGIA WITH HA COATING— 510(k) K081838

Substantially Equivalent

Gish Biomedical, Inc.

FDA 510(k) clearance K081838 for GISH VISION BLOOD CARDIOPLEGIA WITH HA COATING, Substantially Equivalent on 2009-01-26. Applicant: Gish Biomedical, Inc..

Clearance details

Applicant: Gish Biomedical, Inc.
Product code: Code DTR
Advisory panel: Cardiovascular
Date received: 2008-06-30
Decision date: 2009-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rancho Santa Margarita, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DTR

product code DTR

Other: 1
Total: 1

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.