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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device interventional cardiovascular implant simulation software device
Definition An interventional cardiovascular implant simulation software device is a prescription device that provides a computer simulation of an interventional cardiovascular implant device inside a patient’s cardiovascular anatomy. It performs computational modeling to predict the interaction of the interventional cardiovascular implant device with the patient-specific anatomical environment.
Product CodeQQI
Regulation Number 870.1405
Device Class 2


Premarket Reviews
ManufacturerDecision
DASI SIMULATIONS
  SUBSTANTIALLY EQUIVALENT 1
FEOPS NV
  SUBSTANTIALLY EQUIVALENT 1
  GRANTED 1

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