Nautilus Smart ECMO Module— 510(k) K191935

Substantially Equivalent

Mc3 Incorporated

FDA 510(k) clearance K191935 for Nautilus Smart ECMO Module, Substantially Equivalent on 2020-04-09. Applicant: Mc3 Incorporated.

Clearance details

Applicant: Mc3 Incorporated
Product code: Code BYS
Advisory panel: Cardiovascular
Date received: 2019-07-19
Decision date: 2020-04-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dexter, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BYS

product code BYS

Death: 5
Other: 1
Total: 6

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.