Cleared Special

GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS

K093817 · Vascutek, Ltd. · Cardiovascular
Jan 2010
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K093817 is an FDA 510(k) clearance for the GELWEAVE BRANCHED VASCULAR GRAFTS 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 January 7, 2010, 27 days after receiving the submission on December 11, 2009. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3450.

Submission Details

510(k) Number K093817 FDA.gov
FDA Decision Cleared SESE
Date Received December 11, 2009
Decision Date January 07, 2010
Days to Decision 27 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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