Cleared Traditional

MATRACELL DECELLULARIZED PULMONARY ARTERY PATCH ALLOGRAFT (K081438) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K081438 · Lifenet Health · Cardiovascular device
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Oct 2008
Decision
148d
Days
Class 2
Risk

K081438 is an FDA 510(k) clearance for the MATRACELL DECELLULARIZED PULMONARY ARTERY PATCH ALLOGRAFT. Classified as Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (product code DXZ), Class II - Special Controls.

Submitted by Lifenet Health (Virginia Beach, US). The FDA issued a Cleared decision on October 17, 2008 after a review of 148 days - within the typical 510(k) review window.

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 Lifenet Health devices

Submission Details

510(k) Number K081438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2008
Decision Date October 17, 2008
Days to Decision 148 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
23d slower than avg
Panel avg: 125d · This submission: 148d
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 23
Devices cleared under the same product code (DXZ) and FDA review panel - the closest regulatory comparables to K081438.
Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch
K200955 · Vascutek, Ltd. · Jul 2020
PremiPatch PTFE Pledget
K151865 · Aesculap, Inc. · Oct 2015
EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700
K082139 · Edwards Lifesciences, LLC · Oct 2008
PTFE FELTS AND PLEDGETS
K041716 · Boston Scientific Corp · Jul 2004
PRECLUDE PERICARDIAL MEMBRANE
K012098 · W.L. Gore & Associates, Inc. · Sep 2001
ETHIBOND EXCEL VALVE LOOP SUTURE
K003070 · Ethicon, Inc. · Nov 2000