Cleared Traditional

VASCUTEK TWILLWEAVE VASCULAR GRAFT

K964959 · Vascutek, Ltd. · Cardiovascular
Mar 1997
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K964959 is an FDA 510(k) clearance for the VASCUTEK TWILLWEAVE 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 March 10, 1997, 89 days after receiving the submission on December 11, 1996. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3450.

Submission Details

510(k) Number K964959 FDA.gov
FDA Decision Cleared ST
Date Received December 11, 1996
Decision Date March 10, 1997
Days to Decision 89 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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