FDA product code QZU

Temporary Embolization Assist Device, Peripheral

Cardiovascular·Class 2·21 CFR 870.3325
US regulatory classifications
US Product Code (FDA)
QZU
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 870.3325
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Medical specialty
Cardiovascular
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

A temporary coil embolization assist device is a prescription device intended for temporary use in the vasculature to mechanically assist in the embolization of aneurysms with embolic coils. The device is delivered into the vasculature with an endovascular approach. This device is not intended to be permanently implanted and is removed from the body when the procedure is completed.

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About this record

Temporary Embolization Assist Device, Peripheral is a medical device type in the Cardiovascular specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.