Embolization Agent, Vascular
The Vascular Embolization Agent is a material used to intentionally occlude peripheral blood vessels for therapeutic purposes, such as reducing blood supply to tumors, controlling hemorrhage, or treating vascular malformations, by being introduced endovascularly and causing vessel blockage. Given the high risk associated with permanent vascular occlusion, the device is classified as FDA Class 3 requiring Premarket Approval (PMA). It is reviewed under the Cardiovascular panel and flagged as an implant as the material remains in the vasculature. No regulation number is assigned and it is not life-sustaining.
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Basic Information
- Product Code
- QVG
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- CV
- Submission Type
- 2
Device Characteristics
Definition
For occluding peripheral vessels
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.