DeviceClearance

K830806

Substantially Equivalent

VASCULAR GRAFT/BIFURCATED/FEP-RINGED

Applicant
W. L. Gore & Associates, Inc.
Product code
DXZ
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code DXZ

product code DXZ
Death
19
Injury
265
Total
284

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.