Cleared Traditional

VASCUTEK GELSOFT PLUS VASCULAR GRAFT

K955230 · Vascutek, Ltd. · Cardiovascular
Feb 1996
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K955230 is an FDA 510(k) clearance for the VASCUTEK GELSOFT PLUS 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 February 9, 1996, 87 days after receiving the submission on November 14, 1995. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3450.

Submission Details

510(k) Number K955230 FDA.gov
FDA Decision Cleared ST
Date Received November 14, 1995
Decision Date February 09, 1996
Days to Decision 87 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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