SARNS MEMBRANE OXYGENATOR W/INTEGRAL RESERVOIR— 510(k) K870829

Substantially Equivalent

3M Health Care, Sarns

FDA 510(k) clearance K870829 for SARNS MEMBRANE OXYGENATOR W/INTEGRAL RESERVOIR, Substantially Equivalent on 1987-05-06. Applicant: 3M Health Care, Sarns.

Clearance details

Applicant: 3M Health Care, Sarns
Product code: Code DTN
Advisory panel: Cardiovascular
Date received: 1987-03-03
Decision date: 1987-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, 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.