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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original HDE to get an up-to-date view of this device.
Classification Namecatheter, neurovasculature, occluding balloon
Generic Namecatheter, neurovasculature, occluding balloon
Regulation Number882.5150
2000 ringwood ave
san jose, CA 95131
HDE NumberH030005
Supplement NumberS003
Date Received07/22/2014
Decision Date10/03/2014
Product Code
NUF[ Registered Establishments with NUF ]
Advisory Committee Neurology
Supplement Typenormal 75 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for a manufacturing site located at matrix medtech inc. , in maple grove, minnesota.