Cleared Traditional

VASCUTEK BRANCHED GELWEAVE

K090987 · Vascutek, Ltd. · Cardiovascular
Jun 2009
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K090987 is an FDA 510(k) clearance for the VASCUTEK BRANCHED GELWEAVE, a Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (Class II — Special Controls, product code DSY), submitted by Vascutek, Ltd. (Inchinnan, Renfrewshire, GB). The FDA issued a Cleared decision on June 19, 2009, 73 days after receiving the submission on April 7, 2009. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3450.

Submission Details

510(k) Number K090987 FDA.gov
FDA Decision Cleared SESE
Date Received April 07, 2009
Decision Date June 19, 2009
Days to Decision 73 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

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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