SARNS 9000 HEART-LUNG CONSOLE— 510(k) K871131

Substantially Equivalent

3M Health Care, Sarns

FDA 510(k) clearance K871131 for SARNS 9000 HEART-LUNG CONSOLE, Substantially Equivalent on 1987-05-21. Applicant: 3M Health Care, Sarns.

Clearance details

Applicant: 3M Health Care, Sarns
Product code: Code DTQ
Advisory panel: Cardiovascular
Date received: 1987-03-20
Decision date: 1987-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, US

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Adverse events under product code DTQ

product code DTQ

Death: 123
Malfunction: 4,822
Other: 1
Total: 4,946

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.