Not Cleared Traditional

K940062 - DIASTAT VASCULAR ACCESS GRAFT (FDA 510(k) Clearance)

K940062 · W.L. Gore & Associates, Inc. · Cardiovascular device

May 1994

Decision

116d

Days

Class 2

Risk

K940062 is an FDA 510(k) submission for the DIASTAT VASCULAR ACCESS GRAFT. 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 May 2, 1994.

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

Submission Details

510(k) Number	K940062 FDA.gov
FDA Decision	Not Cleared PT (PT)
Date Received	January 06, 1994
Decision Date	May 02, 1994
Days to Decision	116 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	—