GALAXY G3 Mini Microcoil Delivery System

• • Terminated Z-2280-2019 FDA Class II ·initiated 16 May 2019

  Incorrect coil length on the label

510(k) Number

K171862 ↗

FDA Product Code

HCG

Device Class

Class II

Regulation

21 CFR Part 882.5950

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

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See all devices from Codman & Shurtleff, Inc. →