Cleared Traditional

K082139 - EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700

K082139 is an FDA 510(k) clearance for EDWARDS BOVINE PERICARDIAL PATCH, manufactured by Edwards Lifesciences, LLC. The device is a Class 2 Cardiovascular device with product code DXZ cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K082139 · Edwards Lifesciences, LLC · Cardiovascular device
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Oct 2008
Decision
86d
Days
Class 2
Risk

K082139 is an FDA 510(k) clearance for the EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700. Classified as Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (product code DXZ), Class II - Special Controls.

Submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on October 23, 2008 after a review of 86 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 Edwards Lifesciences, LLC devices

FDA 510(k) Submission Details - K082139

510(k) Number K082139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2008
Decision Date October 23, 2008
Days to Decision 86 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
39d faster than avg
Panel avg: 125d · This submission: 86d
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 79
Devices cleared under the same product code (DXZ) and FDA review panel - the closest regulatory comparables to K082139.
CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH
K101866 · Cryolife, Inc. · Jul 2010
CARDIO-WRAP
K090637 · Mast Biosurgery USA, Inc. · Jan 2010
CRYOPATCH SG PULMONARY HEMI-ARTERY
K091626 · Cryolife, Inc. · Aug 2009
MATRACELL DECELLULARIZED PULMONARY ARTERY PATCH ALLOGRAFT
K081438 · Lifenet Health · Oct 2008
CORMATRIX PATCH FOR CARDIAC TISSUE REPAIR
K063349 · Cormatrix Cardiovascular, Inc. · Feb 2007
IVENA VASCULAR PATCH
K060396 · Atrium Medical Corp. · May 2006