Ureteral Stent Systems, Biliary Drainage Catheters— 510(k) K191446

Unknown

Boston Scientific Corporation

FDA 510(k) clearance K191446 for Ureteral Stent Systems, Biliary Drainage Catheters, Unknown on 2020-01-02. Applicant: Boston Scientific Corporation.

Clearance details

Applicant: Boston Scientific Corporation
Product code: Code FAD
Advisory panel: Gastroenterology, Urology
Date received: 2019-05-31
Decision date: 2020-01-02
Decision: Unknown
Clearance type: Traditional
Location: Marborough, 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.