Cleared Traditional

VASCUTEK GELWEAVE VASCULAR GRAFT

K952293 · Vascutek, Ltd. · Cardiovascular
Dec 1995
Decision
217d
Days
Class 2
Risk

About This 510(k) Submission

K952293 is an FDA 510(k) clearance for the VASCUTEK GELWEAVE VASCULAR GRAFT, a Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (Class II — Special Controls, product code DSY), submitted by Vascutek, Ltd. (Austin, US). The FDA issued a Cleared decision on December 19, 1995, 217 days after receiving the submission on May 16, 1995. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3450.

Submission Details

510(k) Number K952293 FDA.gov
FDA Decision Cleared ST
Date Received May 16, 1995
Decision Date December 19, 1995
Days to Decision 217 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

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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