Product Code: QVG FDA class 3

Embolization Agent, Vascular

Unknown

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.

510(k)s
0
FEI Numbers
5
Registration Numbers
5
Unique Applicants
0
Years Active

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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

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

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.