K834373

Substantially Equivalent

CARDIOTOMY RESERVORS BCR-3000/3500-Q-120

Applicant: American Bentley
Product code: DTN
Advisory panel: Cardiovascular
Date received: 1983-12-12
Decision date: 1984-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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.