Cleared Traditional

K081438 - MATRACELL DECELLULARIZED PULMONARY ARTE...

K081438 is an FDA 510(k) clearance for MATRACELL DECELLULARIZED PULMONARY ARTE..., manufactured by Lifenet Health. The device is a Class 2 Cardiovascular device with product code DXZ cleared through the Traditional 510(k) pathway after a 148-day FDA review.

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

FDA 510(k) Submission Details - K081438

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.

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 51
Devices cleared under the same product code (DXZ) and FDA review panel - the closest regulatory comparables to K081438.
PremiPatch PTFE Pledget
K151865 · Aesculap, Inc. · Oct 2015
ALBOSURE POLYESTER VASCULAR PATCH
K101740 · LeMaitre Vascular, Inc. · Sep 2010
EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700
K082139 · Edwards Lifesciences, LLC · Oct 2008
IVENA VASCULAR PATCH
K060396 · Atrium Medical Corp. · May 2006
PTFE FELTS AND PLEDGETS
K041716 · Boston Scientific Corp · Jul 2004
CHASE CARDIOVASCULAR PATCH KIT
K022093 · Chase Medical, Inc. · Sep 2002