Nautilus VF ECMO Oxygenator— 510(k) K232767

Substantially Equivalent

Mc3, Inc.

FDA 510(k) clearance K232767 for Nautilus VF ECMO Oxygenator, Substantially Equivalent on 2023-10-04. Applicant: Mc3, Inc..

Clearance details

Applicant: Mc3, Inc.
Product code: Code BYS
Advisory panel: Cardiovascular
Date received: 2023-09-11
Decision date: 2023-10-04
Decision: Substantially Equivalent
Clearance type: Special
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.