Cleared Traditional

VASCUTEK CANNULA GRAFT, MODEL CGS2008S

K081560 · Vascutek, Ltd. · Cardiovascular

Feb 2009

Decision

252d

Days

Class 2

Risk

About This 510(k) Submission

K081560 is an FDA 510(k) clearance for the VASCUTEK CANNULA GRAFT, MODEL CGS2008S, a Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (Class II — Special Controls, product code DWF), submitted by Vascutek, Ltd. (Renfrewshire, Glasgow, GB). The FDA issued a Cleared decision on February 10, 2009, 252 days after receiving the submission on June 3, 2008. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4210.

Submission Details

510(k) Number	K081560 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 03, 2008
Decision Date	February 10, 2009
Days to Decision	252 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