BLOOD RESERVOIR, CARDIOPULMONARY BYPASS— 510(k) K882414

Substantially Equivalent

Gish Biomedical, Inc.

FDA 510(k) clearance K882414 for BLOOD RESERVOIR, CARDIOPULMONARY BYPASS, Substantially Equivalent on 1988-12-05. Applicant: Gish Biomedical, Inc..

Clearance details

Applicant: Gish Biomedical, Inc.
Product code: Code DTN
Advisory panel: Cardiovascular
Date received: 1988-06-13
Decision date: 1988-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

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Adverse events under product code DTN

product code DTN

Death: 3
Total: 3

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.