GDC 360 DETEACHABLE COIL— 510(k) K103355

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K103355 for GDC 360 DETEACHABLE COIL, Substantially Equivalent on 2011-02-16. Applicant: Boston Scientific Corp.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code HCG
Advisory panel: Neurology
Date received: 2010-11-16
Decision date: 2011-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont, CA, US

Download summary PDF View on FDA.gov ↗

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.