Cleared Traditional

ANTEGRADE CARDIOPLEGIA CANNULA(N-TYPE)

K140569 · Maquet Cardiopulmonary, AG · Cardiovascular

Nov 2014

Decision

258d

Days

Class 2

Risk

About This 510(k) Submission

K140569 is an FDA 510(k) clearance for the ANTEGRADE CARDIOPLEGIA CANNULA(N-TYPE), a Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (Class II — Special Controls, product code DWF), submitted by Maquet Cardiopulmonary, AG (Rastatt De-Bw, DE). The FDA issued a Cleared decision on November 19, 2014, 258 days after receiving the submission on March 6, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4210.

Submission Details

510(k) Number	K140569 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 06, 2014
Decision Date	November 19, 2014
Days to Decision	258 days
Submission Type	Traditional
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