Cleared Traditional

EXTRA SOFT/EXTRA LOW WOVEN VASCULAR PROTHESIS

K910863 · Vascutek, Ltd. · Cardiovascular
Apr 1991
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K910863 is an FDA 510(k) clearance for the EXTRA SOFT/EXTRA LOW WOVEN VASCULAR PROTHESIS, a Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (Class II — Special Controls, product code DSY), submitted by Vascutek, Ltd. (Pa49rr Scotland, GB). The FDA issued a Cleared decision on April 1, 1991, 31 days after receiving the submission on March 1, 1991. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3450.

Submission Details

510(k) Number K910863 FDA.gov
FDA Decision Cleared SESE
Date Received March 01, 1991
Decision Date April 01, 1991
Days to Decision 31 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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