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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device needle, biopsy, cardiovascular
Regulation Description Manual surgical instrument for general use.
Product CodeDWO
Regulation Number 878.4800
Device Class 1


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 2
CIVCO
  SUBSTANTIALLY EQUIVALENT 1
MANAN MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL DEVICE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
VLV ASSOCIATES, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Material separation 6
Other (for use when an appropriate device code cannot be identified) 4
Break 4
Tip breakage 2
Component(s), broken 1
Detachment of device component 1
Fracture 1
Difficult to insert 1
Material rupture 1
Total Device Problems 21

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