FDA 510(k)

Nautilus VF ECMO Oxygenator

K-Number: K232767 · 2023-10-04

Decision Date2023-10-04

Product CodeBYS

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Nautilus VF ECMO Oxygenator is the device name listed in this FDA 510(k) record. The listed applicant is Mc3, Inc.. It received FDA 510(k) clearance on 2023-10-04 under 510(k) 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. The listed applicant is Mc3, Inc.. The 510(k) number is K232767.

When did Nautilus VF ECMO Oxygenator receive FDA 510(k) clearance?

Nautilus VF ECMO Oxygenator received FDA 510(k) clearance on 2023-10-04, under 510(k) number K232767.

Who is the listed applicant for Nautilus VF ECMO Oxygenator?

The FDA 510(k) record lists Mc3, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nautilus VF ECMO Oxygenator?

The FDA product code for Nautilus VF ECMO Oxygenator is BYS.

Other records listing Mc3, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K203409MC3 Crescent Jugular Dual Lumen Catheter K191935Nautilus Smart ECMO Module K182914MC3 Vascular Access Kit 21030 K180151MC3 Jugular Dual Lumen Catheter K171610MC3 QuickFlow Dual Lumen Catheter

Related Devices (Code: BYS)

K191935Nautilus Smart ECMO ModuleMc3 Incorporated

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.