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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ultrasound, infusion, system
Regulation Description Diagnostic intravascular catheter.
Definition 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.
Product CodeNUI
Regulation Number 870.1200
Device Class 2

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