FDA product code OBA

Polymerizing, Neurovascular Embolization Material

Unknown·Class f·21 CFR ·Implantable·Life-sustaining
US regulatory classifications
US Product Code (FDA)
OBA
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US Risk Class (FDA)
Class f
US Regulation (CFR)
21 CFR
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Medical specialty
Unknown
Device characteristics
GMP exempt
No
Implantable
Yes
Life-sustaining
Yes
Third party review
Not Eligible
Definition

The neurovascular embolization device is placed in a blood vessel to permanenty obstruct blood flow to an intracranial aneurysm or other vascular malformation. The device polymerizes or precipitates in situ.

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About this record

Polymerizing, Neurovascular Embolization Material is a medical device type in the Unknown 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. This device type includes implantable products. This device type includes life-sustaining products.

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.