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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


Premarket Reviews
ManufacturerDecision
EKOS CORP.
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - WITH LIMITATIONS 3

Device Problems
Device inoperable 1
Total Device Problems 1

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