K030966

Substantially Equivalent

CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER

Applicant: Boston Scientific Corp
Product code: NAJ
Advisory panel: Cardiovascular
Date received: 2003-03-27
Decision date: 2003-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glens Falls, NY, 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.