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

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.

Clearance details

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

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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.