Cleared Special

VASCUTEK GELWEAVE SIENA COLLARED ANTEFLO AND PLEXUS WITH RADIOPAQUE MARKERS

K060142 · Vascutek, Ltd. · Cardiovascular
Feb 2006
Decision
19d
Days
Class 2
Risk

About This 510(k) Submission

K060142 is an FDA 510(k) clearance for the VASCUTEK GELWEAVE SIENA COLLARED ANTEFLO AND PLEXUS WITH RADIOPAQUE MARKERS, a Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (Class II — Special Controls, product code DSY), submitted by Vascutek, Ltd. (Renfrewshire, Glasgow, GB). The FDA issued a Cleared decision on February 7, 2006, 19 days after receiving the submission on January 19, 2006. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3450.

Submission Details

510(k) Number K060142 FDA.gov
FDA Decision Cleared SESE
Date Received January 19, 2006
Decision Date February 07, 2006
Days to Decision 19 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

Product Code DSY — Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.3450

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