SINGLE PASS BLOOD CARDIOPLEGIA SPBC SYSTEM COMPONENTS— 510(k) K944219

Substantially Equivalent

Gish Biomedical, Inc.

FDA 510(k) clearance K944219 for SINGLE PASS BLOOD CARDIOPLEGIA SPBC SYSTEM COMPONENTS, Substantially Equivalent on 1995-06-30. Applicant: Gish Biomedical, Inc..

Clearance details

Applicant: Gish Biomedical, Inc.
Product code: Code DTR
Advisory panel: Cardiovascular
Date received: 1994-08-29
Decision date: 1995-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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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.