Tria Firm Ureteral Stent— 510(k) K190603

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K190603 for Tria Firm Ureteral Stent, Substantially Equivalent on 2019-05-24. Applicant: Boston Scientific Corporation.

Clearance details

Applicant: Boston Scientific Corporation
Product code: Code FAD
Advisory panel: Gastroenterology, Urology
Date received: 2019-03-08
Decision date: 2019-05-24
Decision: Substantially Equivalent
Clearance type: Special
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, 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.