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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device sizer, heart-valve, prosthesis
Regulation Description Prosthetic heart valve sizer.
Product CodeDTI
Regulation Number 870.3945
Device Class 1


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
CARBOMEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Crack 84
Component missing 68
Unknown (for use when the device problem is not known) 18
Break 10
Fracture 6
Other (for use when an appropriate device code cannot be identified) 3
No code available 1
Component(s), broken 1
Dislodged 1
Total Device Problems 192

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