Cleared Traditional

K093934 - GORE HYBRID VASCULAR GRAFT

K093934 is an FDA 510(k) clearance for GORE HYBRID VASCULAR GRAFT, manufactured by W.L. Gore & Associates. The device is a Class 2 Cardiovascular device with product code DSY cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K093934 · W.L. Gore & Associates · Cardiovascular device
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Mar 2010
Decision
85d
Days
Class 2
Risk

K093934 is an FDA 510(k) clearance for the GORE HYBRID VASCULAR GRAFT. Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by W.L. Gore & Associates (Flagstaff, US). The FDA issued a Cleared decision on March 17, 2010 after a review of 85 days - a notably fast clearance cycle.

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 establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all W.L. Gore & Associates devices

FDA 510(k) Submission Details - K093934

510(k) Number K093934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2009
Decision Date March 17, 2010
Days to Decision 85 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 125d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSY Device Classification - Class 2, Special Controls

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 139
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K093934.
ATRIUM FLIXENE IFG VASCULAR GRAFT
K122138 · Atrium Medical Corp. · Aug 2012
EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDARD WALL,THIN WALL
K113101 · Boston Scientific Corporation · Jan 2012
ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT
K102596 · Atrium Medical Corp. · Oct 2010
GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS
K093817 · Vascutek, Ltd. · Jan 2010
MAXIFLO, TAPERFLO
K092863 · Vascutek, Ltd. · Oct 2009
VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTS
K091778 · Vascutek, Ltd. · Aug 2009