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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device percutaneous catheter for electrosurgical cutting heart valve leaflets concomitant to transcatheter valve procedures
Definition The device is intended for electrosurgically splitting valve leaflets to facilitate a planned valvular procedure
Product CodeSGO
Regulation Number 870.1254
Device Class 2


Premarket Reviews
ManufacturerDecision
TELLTALE, LLC
  SUBSTANTIALLY EQUIVALENT 1

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