510(k) K012883— ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM

Unknown

Boston Scientific Corp

Clearance details

Applicant: Boston Scientific Corp
Product code: Code ESW
Advisory panel: General, Plastic Surgery
Date received: 2001-08-28
Decision date: 2001-10-12
Decision: Unknown
Clearance type: Special
Location: Natick,, MA, US

Adverse events under product code ESW

product code ESW

Death: 11
Injury: 353
Malfunction: 442
Total: 806

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.