CARDIOTOMY RESERVOIRS— 510(k) K820727

Substantially Equivalent

Erik Perfusion Services

FDA 510(k) clearance K820727 for CARDIOTOMY RESERVOIRS, Substantially Equivalent on 1982-07-08. Applicant: Erik Perfusion Services.

Clearance details

Applicant: Erik Perfusion Services
Product code: Code DTN
Advisory panel: Cardiovascular
Date received: 1982-03-17
Decision date: 1982-07-08
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.