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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.
 
Trade NameNEUROFLO CATHETER 7F
Classification Namecatheter, neurovasculature, occluding balloon
Generic Namecatheter, neurovasculature, occluding balloon
Regulation Number882.5150
Applicant
Zoll Circulation
2000 ringwood ave.
san jose, CA 95131
HDE NumberH030005
Supplement NumberS003
Date Received07/22/2014
Decision Date10/03/2014
Product Code
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.
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