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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device angiographic coronary vascular physiologic simulation software
Definition An angiographic coronary vascular physiologic simulation software device is intended to aid in the identification of functionally significant cardiovascular disease.
Product CodeQEK
Regulation Number 870.1415
Device Class 2


Premarket Reviews
ManufacturerDecision
CATHWORKS LTD
  SUBSTANTIALLY EQUIVALENT 1

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