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Ultrasound, Infusion, System

FDA product code NUI · 4 cleared devices

Class 2 Cardiovascular
Regulation
21 CFR 870.1200
Review panel
NE
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2005-04-27 – 2006-12-05

For regional infusion of contrast materials into selected vessels in the neuro-vasculature. The device may be used for controlled, regional infusion into selected vessels and is not intended for use in the coronary vasculature.

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