NAVIGATOR HD URETERAL ACCESS SHEATH SETS— 510(k) K140323

Substantially Equivalent

Boston Scientific

FDA 510(k) clearance K140323 for NAVIGATOR HD URETERAL ACCESS SHEATH SETS, Substantially Equivalent on 2014-03-07. Applicant: Boston Scientific.

Clearance details

Applicant: Boston Scientific
Product code: Code FED
Advisory panel: Gastroenterology, Urology
Date received: 2014-02-10
Decision date: 2014-03-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Marlboro, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FED

product code FED

Death: 10
Total: 10

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.