MODIFIED SARNS MEMBRANE OXYGENATOR— 510(k) K863902

Substantially Equivalent

3M Health Care, Sarns

FDA 510(k) clearance K863902 for MODIFIED SARNS MEMBRANE OXYGENATOR, Substantially Equivalent on 1986-12-11. Applicant: 3M Health Care, Sarns.

Clearance details

Applicant: 3M Health Care, Sarns
Product code: Code DTX
Advisory panel: Cardiovascular
Date received: 1986-10-07
Decision date: 1986-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, US

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Adverse events under product code DTX

product code DTX

Death: 3
Malfunction: 497
Total: 500

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.