Cleared Traditional

K012098 - PRECLUDE PERICARDIAL MEMBRANE

K012098 is the FDA 510(k) clearance for PRECLUDE PERICARDIAL MEMBRANE 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 77-day FDA review.

K012098 · W.L. Gore & Associates, Inc. · Cardiovascular device
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Sep 2001
Decision
77d
Days
Class 2
Risk

K012098 is an FDA 510(k) clearance for the PRECLUDE PERICARDIAL MEMBRANE. Classified as Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (product code DXZ), Class II - Special Controls.

Submitted by W.L. Gore & Associates, Inc. (Elkton, US). The FDA issued a Cleared decision on September 20, 2001 after a review of 77 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 K012098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2001
Decision Date September 20, 2001
Days to Decision 77 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
48d faster than avg
Panel avg: 125d · This submission: 77d
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 K012098.
EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700
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IVENA VASCULAR PATCH
K060396 · Atrium Medical Corp. · May 2006
PTFE FELTS AND PLEDGETS
K041716 · Boston Scientific Corp · Jul 2004
SURGISIS PERIPHERAL VASCULAR PATCH
K001785 · Cook Biotech, Inc. · Dec 2000
ETHIBOND EXCEL VALVE LOOP SUTURE
K003070 · Ethicon, Inc. · Nov 2000
UNI-GRAFT K DV PATCH
K992776 · Atrium Medical Corp. · Nov 1999