Not Cleared Traditional

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

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K941981 · W.L. Gore & Associates, Inc. · Cardiovascular device
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Jul 1994
Decision
97d
Days
Class 2
Risk

K941981 is an FDA 510(k) submission (not cleared) for the AXILLOBIFEMORAL GORE-TEX CASCULAR GRAFT,BIFURCATED. Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by W.L. Gore & Associates, Inc. (Flagstaff, US). The FDA issued a Not Cleared (DENG) decision on July 20, 1994 after a review of 97 days.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3450 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Cardiovascular review framework.

View all W.L. Gore & Associates, Inc. devices

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 -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 125d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3450
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

All 39
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K941981.
EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED VASCULAR GRAFTS, WOVEN DOUBLE VELOUR WOVEN
K052964 · Boston Scientific Corp · Jan 2006
BARD GRAFT SIZER
K961134 · C.R. Bard, Inc. · Jun 1996
BARD EXPANDED PTFE VASCULAR GRAFT(MODIFICATION)
K954582 · C.R. Bard, Inc. · Dec 1995
BARD(R) EXPANDED PTFE VASCULAR GRAFT
K940816 · C.R. Bard, Inc. · Jun 1994
BAXTER REINFORCED EXPANDED PTFE VASCULAR GRAFT
K933590 · Baxter Healthcare Corp · Jan 1994
BARD PTFE VASCULAR GRAFT
K933204 · C.R. Bard, Inc. · Oct 1993