• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification

  • Print
  • Share
  • E-mail
New Search Back to Search Results
Device temporary percutaneous transluminal cerebral artery dilatation device
Definition Used to temporarily dilate and increase the diameter of cerebral arteries experiencing symptomatic vasospasm
Physical State The device is composed of a self-expanding stent-like component affixed to the end of a pusher wire.
Technical Method The device is delivered percutaneously to the target artery in the neurovasculature. The stent-like component of the device temporarily dilates and expands the diameter of the cerebral artery experiencing symptomatic vasospasm to improve blood flow. The device is removed from the body at the end of the procedure.
Target Area Neurovasculature
Review Panel Neurology
Product CodeQTK
Premarket Review Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Submission Type HDE - Humanitarian Device Exemption
Device Class HDE
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible