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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device software for visualization of vascular anatomy and intravascular devices
Definition Visualization and measurement of blood vessels and intravascular devices for preoperational planning.
Product CodePZO
Regulation Number 892.2050
Device Class 2


Premarket Reviews
ManufacturerDecision
ARTERYFLOW TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ENDO VANTAGE, LLC
  SUBSTANTIALLY EQUIVALENT 1
MENTICE SPAIN S.L.
  SUBSTANTIALLY EQUIVALENT 1
SIM&CURE
  SUBSTANTIALLY EQUIVALENT 4

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