DeviceClearance

K191609

Substantially Equivalent

Tria Soft Ureteral Stent

Applicant
Boston Scientific Corporation
Product code
FAD
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Marlboro, MA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code FAD

product code FAD
Death
2
Injury
858
Malfunction
2,651
Other
1
Total
3,512

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.