Cleared Traditional

MC3 Jugular Dual Lumen Catheter

K180151 · Mc3 Incorporated · Cardiovascular

Jul 2018

Decision

178d

Days

Class 2

Risk

About This 510(k) Submission

K180151 is an FDA 510(k) clearance for the MC3 Jugular Dual Lumen Catheter, a Dual Lumen Ecmo Cannula (Class II — Special Controls, product code PZS), submitted by Mc3 Incorporated (Dexter, US). The FDA issued a Cleared decision on July 16, 2018, 178 days after receiving the submission on January 19, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4100.

Submission Details

510(k) Number	K180151 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 19, 2018
Decision Date	July 16, 2018
Days to Decision	178 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	PZS — Dual Lumen Ecmo Cannula
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.4100
Definition	Long Term Support Greater Than 6 Hours For Acute Respiratory Or Acute Cardiopulmonary Failure, Where Other Available Treatment Options Have Failed, And Continued Clinical Deterioration Is Expected Or The Risk Of Death Is Imminent.