Micrus Microcoil System Presidio-18, Model PC4

• • Terminated Z-0845-2011 FDA Unclassified (pre-2012) ·initiated 21 Oct 2010

  The firm has received reports of difficulty connecting to the detachment control cable. Loss of the electrical connection will result in failure to detach the coil for deployment inside an aneurysm.

510(k) Number

K062036 ↗

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 Micrus Endovascular Corporation →