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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 NameNeVa VS
Classification Nametemporary percutaneous transluminal cerebral artery dilatation device
Generic Nametemporary percutaneous transluminal cerebral artery dilatation device
Applicant
Vesalio
2305 historic decatur rd.
suite 100
san diego, CA 92106
HDE NumberH210004
Supplement NumberS002
Date Received02/25/2025
Decision Date03/11/2025
Product Code
QTK[ Registered Establishments with QTK ]
Advisory Committee Neurology
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for an increased pushwire length for the neva vs.
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