510(k) K000281— WALLSTENT ENTERNAL PROSTHESIS

Substantially Equivalent

Boston Scientific Corp

Clearance details

Applicant: Boston Scientific Corp
Product code: Code MQR
Advisory panel: General, Plastic Surgery
Date received: 2000-01-31
Decision date: 2000-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Natick,, MA, US

Adverse events under product code MQR

product code MQR

Death: 11
Injury: 149
Total: 160

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.