FDA product code NUF

Catheter, Neurovasculature, Occluding Balloon

Neurology·Class 3·21 CFR 882.5150·Life-sustaining
US regulatory classifications
US Product Code (FDA)
NUF
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US Risk Class (FDA)
Class 3
US Regulation (CFR)
21 CFR 882.5150
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Medical specialty
Neurology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
Yes
Third party review
Not Eligible
Definition

Call for PMAs - 12/26/96 per 61 FR 50708 on 9/27/96 - For the treatment of cerebral ischemia resulting from symptomatic vasospasm following aneurismal subarachnoid hemorrhage, secured by either surgical or endovascular intervention for patients who have failed maximal medical management

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About this record

Catheter, Neurovasculature, Occluding Balloon is a medical device type in the Neurology 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 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.