Nautilus VF ECMO Oxygenator

FDA 510(k) K232767 · Mc3, Inc.

Substantially Equivalent

510(k) numberK232767

Submission

Device name
Nautilus VF ECMO Oxygenator
Applicant
Mc3, Inc.
Dexter, MI, US
Received
September 11, 2023
Decision date
October 4, 2023
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
BYS – Oxygenator, Long Term Support Greater Than 6 Hours
Device class
Class II (moderate risk)
Regulation
21 CFR 870.4100
Specialty
Cardiovascular
Life-sustaining
Yes

Other 510(k)s with product code BYS

510(k)DeviceApplicantDecision
K191935Nautilus Smart ECMO ModuleBYS · Traditional Mc3 Incorporated04/09/2020SE
K770720Tubing Pack, Extracorporeal, H-3000BYS · Traditional William Harvey Life Products Corp.08/04/1977SE

More from William Harvey Life Products Corp.

510(k)DeviceDecision
K203409MC3 Crescent Jugular Dual Lumen CatheterPZS · Traditional 05/03/2021SE
K191935Nautilus Smart ECMO ModuleBYS · Traditional 04/09/2020SE
K182914MC3 Vascular Access Kit 21030DRE · Traditional 10/29/2018SE
K180151MC3 Jugular Dual Lumen CatheterPZS · Traditional 07/16/2018SE
K171610MC3 QuickFlow Dual Lumen CatheterPZS · Traditional 11/16/2017SE

Questions and answers

When was Nautilus VF ECMO Oxygenator cleared by the FDA?

Nautilus VF ECMO Oxygenator (K232767) received a 510(k) decision of Substantially Equivalent on October 4, 2023, 23 days after the submission was received.

What is the product code of K232767?

The FDA product code is BYS – Oxygenator, Long Term Support Greater Than 6 Hours, a Class II (moderate risk) device regulated under 21 CFR 870.4100.