DeviceClearance

ARTIA Reconstructive Tissue Matrix Perforated— 510(k) K162752

Substantially Equivalent

Lifecell Corporation

FDA 510(k) clearance K162752 for ARTIA Reconstructive Tissue Matrix Perforated, Substantially Equivalent on 2017-02-24. Applicant: Lifecell Corporation.

Clearance details

Applicant
Lifecell Corporation
Product code
Code FTM
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Branchburg, NJ, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code FTM

product code FTM
Death
17
Injury
2,174
Total
2,191

Source: openFDA MAUDE database, through . 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.