CONTOUR SE MICROSPHERES— 510(k) K022427

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K022427 for CONTOUR SE MICROSPHERES, Substantially Equivalent on 2002-08-22. Applicant: Boston Scientific Corp.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code HCG
Advisory panel: Neurology
Date received: 2002-07-25
Decision date: 2002-08-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Glens Falls, NY, US

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Adverse events under product code HCG

product code HCG

Death: 50
Injury: 801
Malfunction: 5,625
Total: 6,476

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.