Micrus Microcoli System, Deltaplush, Models Cpl, Dpl

• • 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

K083646 ↗

FDA Product Code

HCG

Device Class

Class II

Regulation

21 CFR Part 882.5950

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Micrus Microcoil System Cashmere-Cerecyte, Model CRC; Cashmere-SR, Model SRC

  Class II

  FDA 510(k) K072173 Active Cleared 5 Oct 2007

• Micrus Ascent Occlusion Balloon Catheter

  Class II

  FDA 510(k) K080861 Active Cleared 27 Aug 2008

• Micrus Microcoil System, Cashmere Model Src

  Class II

  FDA 510(k) K063653 Active Cleared 17 Jan 2007

• Micrus Microcoil System Presidio-18, Model PC4

  Class II

  FDA 510(k) K062036 Active Cleared 25 Aug 2006

• Micrus Microcatheter, Model Courier 270

  Class II

  FDA 510(k) K092702 Active Cleared 20 Nov 2009

• Micrus Microcoil System, Deltapaq 10 Cerecyte, Model Cdf

  Class II

  FDA 510(k) K080437 Active Cleared 8 May 2008

See all devices from Micrus Endovascular Corporation →