Cleared Traditional

K914448 - GORE-TEX CARDIOVASCULAR PATCH

K914448 is the FDA 510(k) clearance for GORE-TEX CARDIOVASCULAR PATCH by W.L. Gore & Associates, Inc.. It is a Class 2 Cardiovascular device (product code DXZ) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K914448 · W.L. Gore & Associates, Inc. · Cardiovascular device
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Nov 1991
Decision
32d
Days
Class 2
Risk

K914448 is an FDA 510(k) clearance for the GORE-TEX(R) CARDIOVASCULAR PATCH, PROCESS CHANGE. 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 November 5, 1991 after a review of 32 days - a notably fast clearance 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: 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, Inc. devices

Submission Details

510(k) Number K914448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1991
Decision Date November 05, 1991
Days to Decision 32 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
93d faster than avg
Panel avg: 125d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 37
Devices cleared under the same product code (DXZ) and FDA review panel - the closest regulatory comparables to K914448.
GORE-TEX CARDIOVASCULAR PATCH
K940906 · W.L. Gore & Associates, Inc. · May 1994
GORE-TEX CARDIOVASCULAR PATCH & SURGICAL MEMBRANE
K930950 · W.L. Gore & Associates, Inc. · Oct 1993
HEMASHIELD MICROVEL/WOVEN DOUBLE VELOUR FABRIC
K931386 · Meadox Medicals, Div. Boston Scientific Corp. · May 1993
GORE-TEX(R) SURGICAL MEMBRANE, PROCESS CHANGE
K914450 · W.L. Gore & Associates, Inc. · Nov 1991
GORE-TEX EXPANDED POLY. CARD. PATCH 0.6 AND 0.4MM
K912107 · W.L. Gore & Associates, Inc. · Oct 1991
GORE-TEX(R) EXPANDED PTFE SURGICAL MEMBRANE
K910464 · W.L. Gore & Associates, Inc. · Mar 1991