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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

Device Problems
Fracture 3
Appropriate Term/Code Not Available 1
Material Fragmentation 1
Crack 1
Total Device Problems 6

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic CoreValve LLC II Feb-14-2020

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