K093919

Substantially Equivalent

MICROPLEX COIL SYSTEM-COSMOS MODEL 100933CSSR-V, 101036CSSR-V, 101141CSSR-V, 101245CSSR-V

Applicant: MicroVention, Inc.
Product code: HCG
Advisory panel: Neurology
Date received: 2009-12-22
Decision date: 2010-01-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Tistin, CA, US

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.