K100663

Substantially Equivalent

CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321

Applicant: Boston Scientific Corporation
Product code: NAJ
Advisory panel: Cardiovascular
Date received: 2010-03-08
Decision date: 2010-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maple Grove, MN, US

Adverse events under product code NAJ

product code NAJ

Death: 3
Total: 3

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.