GUGLIELMI DETACHABLE COIL (GDC)— 510(k) K031049

Substantially Equivalent

Boston Scientific, Target

FDA 510(k) clearance K031049 for GUGLIELMI DETACHABLE COIL (GDC), Substantially Equivalent on 2003-08-01. Applicant: Boston Scientific, Target.

Clearance details

Applicant: Boston Scientific, Target
Product code: Code HCG
Advisory panel: Neurology
Date received: 2003-04-02
Decision date: 2003-08-01
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.