Cleared Traditional

Nautilus Smart ECMO Module

K191935 · Mc3 Incorporated · Cardiovascular

Apr 2020

Decision

265d

Days

Class 2

Risk

About This 510(k) Submission

K191935 is an FDA 510(k) clearance for the Nautilus Smart ECMO Module, a Oxygenator, Long Term Support Greater Than 6 Hours (Class II — Special Controls, product code BYS), submitted by Mc3 Incorporated (Dexter, US). The FDA issued a Cleared decision on April 9, 2020, 265 days after receiving the submission on July 19, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4100.

Submission Details

510(k) Number	K191935 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 19, 2019
Decision Date	April 09, 2020
Days to Decision	265 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF