Cleared Special

MC2X MULTI-STAGE VENOUS CANNULA, MODELS 91437, 91437C

K052372 · Medtronic Perfusion Systems · Cardiovascular
Sep 2005
Decision
23d
Days
Class 2
Risk

About This 510(k) Submission

K052372 is an FDA 510(k) clearance for the MC2X MULTI-STAGE VENOUS CANNULA, MODELS 91437, 91437C, a Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (Class II — Special Controls, product code DWF), submitted by Medtronic Perfusion Systems (Minneapolis, US). The FDA issued a Cleared decision on September 22, 2005, 23 days after receiving the submission on August 30, 2005. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4210.

Submission Details

510(k) Number K052372 FDA.gov
FDA Decision Cleared SESE
Date Received August 30, 2005
Decision Date September 22, 2005
Days to Decision 23 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4210

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