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FDA 510(k)

Nautilus Smart ECMO Module

K-Number: K191935 · 2020-04-09

ApplicantMc3 Incorporated
Decision Date2020-04-09
Product CodeBYS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Nautilus Smart ECMO Module is a medical device manufactured by Mc3 Incorporated. It received FDA 510(k) clearance on 2020-04-09 under approval number K191935. 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 Smart ECMO Module?

Nautilus Smart ECMO Module is a medical device that received FDA 510(k) clearance on 2020-04-09. It is manufactured by Mc3 Incorporated. The 510(k) number is K191935.

When was Nautilus Smart ECMO Module approved by the FDA?

Nautilus Smart ECMO Module received FDA 510(k) clearance on 2020-04-09, under approval number K191935.

What company makes Nautilus Smart ECMO Module?

Nautilus Smart ECMO Module is manufactured by Mc3 Incorporated.

What is the FDA product code for Nautilus Smart ECMO Module?

The FDA product code for Nautilus Smart ECMO Module is BYS.

Other Devices by Mc3 Incorporated

K171610MC3 QuickFlow Dual Lumen Catheter K182914MC3 Vascular Access Kit 21030 K180151MC3 Jugular Dual Lumen Catheter

Related Devices (Code: BYS)

K232767Nautilus VF ECMO OxygenatorMc3, Inc.

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.

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