Nautilus Smart ECMO Module

FDA 510(k) K191935 · Mc3 Incorporated

Substantially Equivalent

510(k) numberK191935

Submission

Device name
Nautilus Smart ECMO Module
Applicant
Mc3 Incorporated
Dexter, MI, US
Received
July 19, 2019
Decision date
April 9, 2020
Decision
Substantially Equivalent (SESE)
Type
Traditional 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
K232767Nautilus VF ECMO OxygenatorBYS · Special Mc3, Inc.10/04/2023SE
K770720Tubing Pack, Extracorporeal, H-3000BYS · Traditional William Harvey Life Products Corp.08/04/1977SE

More from William Harvey Life Products Corp.

510(k)DeviceDecision
K232767Nautilus VF ECMO OxygenatorBYS · Special 10/04/2023SE
K203409MC3 Crescent Jugular Dual Lumen CatheterPZS · Traditional 05/03/2021SE
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 Smart ECMO Module cleared by the FDA?

Nautilus Smart ECMO Module (K191935) received a 510(k) decision of Substantially Equivalent on April 9, 2020, 265 days after the submission was received.

What is the product code of K191935?

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.