MATRACELL DECELLULARIZED PULMONARY ARTERY PATCH ALLOGRAFT— 510(k) K081438

Name: FDA 510(k) clearance K081438
Creator: U.S. Food and Drug Administration
Published: 2008-10-17

Substantially Equivalent

Lifenet Health

FDA 510(k) clearance K081438 for MATRACELL DECELLULARIZED PULMONARY ARTERY PATCH ALLOGRAFT, Substantially Equivalent on 2008-10-17. Applicant: Lifenet Health. Device class: 2.

Clearance details

Applicant: Lifenet Health
Product code: Code DXZ
Device class: Class 2
Regulation: 21 CFR 870.3470
Advisory panel: Cardiovascular
Date received: 2008-05-22
Decision date: 2008-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Virginia Beach, VA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DXZ

view all

K240775 — PeriBeam® Pericardial Membrane2025-04-18
K200955 — Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch2020-07-08
K162506 — PhotoFix Decellularized Bovine Pericardium2017-03-09
K162579 — VascuCel2016-10-14
K152127 — CorMatrix Tyke2016-02-04

More clearances from Lifenet Health

view all

K242799 — PliaFX Flo2024-11-21
K201338 — Allograft MIS Delivery System2020-07-13

Adverse events under product code DXZ

product code DXZ

Death: 19
Injury: 265
Total: 284

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.