DeviceClearance

K142429

Substantially Equivalent

CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2 Microcoil Delivery System, EnPower Control Cable, Connector Cable

Applicant
Codman & Shurtleff, Inc.
Product code
HCG
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Raynham, MA, 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, through . 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.