K843888

Substantially Equivalent

CARDIOTOMY RESERVOIR BRS-XXX SERIES &

Applicant: Gish Biomedical, Inc.
Product code: DTN
Advisory panel: Cardiovascular
Date received: 1984-10-02
Decision date: 1985-02-14
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.