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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device balloon aortic valvuloplasty
Regulation Description Percutaneous catheter.
Definition A balloon aortic valvuloplasty catheter is indicated for balloon valvuloplasty of the aortic valve.
Product CodeOZT
Regulation Number 870.1250
Device Class 2


Premarket Reviews
ManufacturerDecision
NUMED, INC.
  CLEARED FOR MARKETING AUTOMATIC CLASS III DESIGNAT 1
  SUBSTANTIALLY EQUIVALENT 1

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