Last synced on 12 July 2024 at 11:04 pm

Temporary Percutaneous Transluminal Cerebral Artery Dilatation Device

Page Type
Product Code
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
Submission Type
HDE - Humanitarian Device Exemption
Device Classification
F
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

The FDA has not linked product code QTK to any particular section of the CFR (Code of Federal Regulations). There are multiple reasons why this might be the case:

  • The product code was created for a class III submission that does not follow the normal PMN or PMA path - e.g., for a device that falls under HDE (Humanitarian Device Exemption) or EUA (Emergency Use Authorization).
  • The FDA has generated the product code for an existing Class III device, as a result of a PMA supplement that modifies the device in a way that it can't fit under the existing product code originally assigned
  • The product code was created for internal use at the FDA, and not for classification or regulatory-related purposes.

Temporary Percutaneous Transluminal Cerebral Artery Dilatation Device

Page Type
Product Code
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
Submission Type
HDE - Humanitarian Device Exemption
Device Classification
F
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

The FDA has not linked product code QTK to any particular section of the CFR (Code of Federal Regulations). There are multiple reasons why this might be the case:

  • The product code was created for a class III submission that does not follow the normal PMN or PMA path - e.g., for a device that falls under HDE (Humanitarian Device Exemption) or EUA (Emergency Use Authorization).
  • The FDA has generated the product code for an existing Class III device, as a result of a PMA supplement that modifies the device in a way that it can't fit under the existing product code originally assigned
  • The product code was created for internal use at the FDA, and not for classification or regulatory-related purposes.