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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 cutting or splitting heart valve leaflets concomitant to transcatheter valve procedures
Definition The device is a single use percutaneous catheter system intended for mechanically splitting aortic valve leaflets that may prevent coronary artery ostia obstruction during planned transcatheter valve procedures.
Product CodeSCZ
Regulation Number 870.1254
Device Class 2


Premarket Reviews
ManufacturerDecision
PI-CARDIA, LTD.
  GRANTED 1

MDR Year MDR Reports MDR Events
2025 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult or Delayed Positioning 2 2
Break 1 1
Improper or Incorrect Procedure or Method 1 1
Inadequate or Insufficient Training 1 1
Unraveled Material 1 1
Entrapment of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Cardiac Perforation 2 2
Cardiac Tamponade 2 2
Foreign Body In Patient 1 1
Insufficient Information 1 1
Pericardial Effusion 1 1
Pulmonary Embolism 1 1

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