Cleared Traditional

MC3 Crescent Jugular Dual Lumen Catheter

K203409 · Mc3, Inc. · Cardiovascular
May 2021
Decision
165d
Days
Class 2
Risk

About This 510(k) Submission

K203409 is an FDA 510(k) clearance for the MC3 Crescent Jugular Dual Lumen Catheter, a Dual Lumen Ecmo Cannula (Class II — Special Controls, product code PZS), submitted by Mc3, Inc. (Dexter, US). The FDA issued a Cleared decision on May 3, 2021, 165 days after receiving the submission on November 19, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4100.

Submission Details

510(k) Number K203409 FDA.gov
FDA Decision Cleared SESE
Date Received November 19, 2020
Decision Date May 03, 2021
Days to Decision 165 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.