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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, vascular graft, of less then 6mm diameter
Regulation Description Vascular graft prosthesis.
Product CodeDYF
Regulation Number 870.3450
Device Class 2

Device Problems
Torn Material 23
Leak / Splash 10
Adverse Event Without Identified Device or Use Problem 6
Occlusion Within Device 4
Material Split, Cut or Torn 3
Device Contamination with Chemical or Other Material 2
Hole In Material 2
Material Perforation 1
Split 1
Packaging Problem 1
Material Rupture 1
Obstruction of Flow 1
Compatibility Problem 1
Total Device Problems 56


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