CARDIOTOMY RESERVOIR W/FILTER BCR-3500— 510(k) K842620

Substantially Equivalent

American Bentley

FDA 510(k) clearance K842620 for CARDIOTOMY RESERVOIR W/FILTER BCR-3500, Substantially Equivalent on 1984-08-27. Applicant: American Bentley.

Clearance details

Applicant: American Bentley
Product code: Code DTN
Advisory panel: Cardiovascular
Date received: 1984-07-05
Decision date: 1984-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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.