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FDA 510(k)

MATRACELL DECELLULARIZED PULMONARY ARTERY PATCH ALLOGRAFT

K-Number: K081438 · 2008-10-17

ApplicantLifenet Health
Decision Date2008-10-17
Product CodeDXZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MATRACELL DECELLULARIZED PULMONARY ARTERY PATCH ALLOGRAFT is the device name listed in this FDA 510(k) record. The listed applicant is Lifenet Health. It received FDA 510(k) clearance on 2008-10-17 under 510(k) number K081438. The device is classified under product code DXZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MATRACELL DECELLULARIZED PULMONARY ARTERY PATCH ALLOGRAFT?

MATRACELL DECELLULARIZED PULMONARY ARTERY PATCH ALLOGRAFT is a medical device that received FDA 510(k) clearance on 2008-10-17. The listed applicant is Lifenet Health. The 510(k) number is K081438.

When did MATRACELL DECELLULARIZED PULMONARY ARTERY PATCH ALLOGRAFT receive FDA 510(k) clearance?

MATRACELL DECELLULARIZED PULMONARY ARTERY PATCH ALLOGRAFT received FDA 510(k) clearance on 2008-10-17, under 510(k) number K081438.

Who is the listed applicant for MATRACELL DECELLULARIZED PULMONARY ARTERY PATCH ALLOGRAFT?

The FDA 510(k) record lists Lifenet Health as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MATRACELL DECELLULARIZED PULMONARY ARTERY PATCH ALLOGRAFT?

The FDA product code for MATRACELL DECELLULARIZED PULMONARY ARTERY PATCH ALLOGRAFT is DXZ.

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Other records listing Lifenet Health as applicant

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Related Devices (Code: DXZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240775PeriBeam® Pericardial MembraneTamabioK200955Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid PatchVascutek, Ltd.K162506PhotoFix Decellularized Bovine PericardiumCryolife, Inc.K162579VascuCelAdmedus Regen Pty, Ltd.K152127CorMatrix TykeCormatrix Cardiovascular, Inc.K122306SYNOVIS COLLAGEN MATRIX (TBD)Synovis Surgical Innovations

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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