DeviceClearance

K082356

Substantially Equivalent

GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE

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

Adverse events under product code DYB

product code DYB
Death
808
Injury
5,922
Malfunction
16,516
Other
5
Total
23,251

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.