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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, intravascular, plaque morphology evaluation
Regulation Description Diagnostic intravascular catheter.
Definition Catheter used for delivery of a sensing modality to a coronary or peripheral artery region for determination of atherosclerotic plaque characteristics. For examination of morphologic features of coronary or peripheral artery lesions or plaques.
Product CodeOGZ
Regulation Number 870.1200
Device Class 2


Premarket Reviews
ManufacturerDecision
INFRAREDX, INC.
  SUBSTANTIALLY EQUIVALENT 6

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