Nautilus VF ECMO Oxygenator
K-Number: K232767 · 2023-10-04
ApplicantMc3, Inc.
Decision Date2023-10-04
Product CodeBYS
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Nautilus VF ECMO Oxygenator is a medical device manufactured by Mc3, Inc.. It received FDA 510(k) clearance on 2023-10-04 under approval number K232767. The device is classified under product code BYS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Nautilus VF ECMO Oxygenator?
Nautilus VF ECMO Oxygenator is a medical device that received FDA 510(k) clearance on 2023-10-04. It is manufactured by Mc3, Inc.. The 510(k) number is K232767.
When was Nautilus VF ECMO Oxygenator approved by the FDA?
Nautilus VF ECMO Oxygenator received FDA 510(k) clearance on 2023-10-04, under approval number K232767.
What company makes Nautilus VF ECMO Oxygenator?
Nautilus VF ECMO Oxygenator is manufactured by Mc3, Inc..
What is the FDA product code for Nautilus VF ECMO Oxygenator?
The FDA product code for Nautilus VF ECMO Oxygenator is BYS.
Other Devices by Mc3, Inc.
Related Devices (Code: BYS)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.