Not Cleared Traditional

K941981 - AXILLOBIFEMORAL GORE-TEX CASCULAR GRAFT,BIFURCATED (FDA 510(k) Clearance)

K941981 · W.L. Gore & Associates, Inc. · Cardiovascular device

Jul 1994

Decision

97d

Days

Class 2

Risk

K941981 is an FDA 510(k) submission for the AXILLOBIFEMORAL GORE-TEX CASCULAR GRAFT,BIFURCATED. This device is classified as a Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (Class II - Special Controls, product code DSY).

Submitted by W.L. Gore & Associates, Inc. (Flagstaff, US). The FDA issued a Not Cleared (DENG) decision on July 20, 1994.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3450.

Submission Details

510(k) Number	K941981 FDA.gov
FDA Decision	Not Cleared PT (PT)
Date Received	April 14, 1994
Decision Date	July 20, 1994
Days to Decision	97 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	—