Cleared Traditional

K930950 - GORE-TEX CARDIOVASCULAR PATCH & SURGICAL MEMBRANE

K930950 is an FDA 510(k) clearance for GORE-TEX CARDIOVASCULAR PATCH & SURGICA..., manufactured by W.L. Gore & Associates, Inc.. The device is a Class 2 Cardiovascular device with product code DXZ cleared through the Traditional 510(k) pathway after a 241-day FDA review.

K930950 · W.L. Gore & Associates, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Oct 1993
Decision
241d
Days
Class 2
Risk

K930950 is an FDA 510(k) clearance for the GORE-TEX CARDIOVASCULAR PATCH & SURGICAL MEMBRANE. Classified as Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (product code DXZ), Class II - Special Controls.

Submitted by W.L. Gore & Associates, Inc. (Flagstaff, US). The FDA issued a Cleared decision on October 22, 1993 after a review of 241 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3470 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

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

FDA 510(k) Submission Details - K930950

510(k) Number K930950 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1993
Decision Date October 22, 1993
Days to Decision 241 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 125d · This submission: 241d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXZ Device Classification - Class 2, Special Controls

Product Code DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3470
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 - DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

All 75
Devices cleared under the same product code (DXZ) and FDA review panel - the closest regulatory comparables to K930950.
CVPRO CARDIOVASCULAR PATCH
K943736 · W.L. Gore & Associates, Inc. · Feb 1995
VASCU-GUARD
K942010 · Bio-Vascular, Inc. · Jul 1994
GORE-TEX CARDIOVASCULAR PATCH
K940906 · W.L. Gore & Associates, Inc. · May 1994
HEMASHIELD MICROVEL/WOVEN DOUBLE VELOUR FABRIC
K931386 · Meadox Medicals, Div. Boston Scientific Corp. · May 1993
TISSUE PATCH, TISSUE GRAFT
K921895 · Bio-Vascular, Inc. · Nov 1992
CARDIOVASCULAR REPAIR PATCH
K905073 · Impra, Inc. · Dec 1991