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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device central venous catheter with manual insertion system
Regulation Description Intravascular catheter.
Definition A central venous catheter with manual insertion system is intended to provide short-term access (<30 days) to the central venous system. The manual insertion system is attached to the catheter and facilitates placement in the targeted vessel.
Product CodeSEF
Regulation Number 880.5200
Device Class 2


Premarket Reviews
ManufacturerDecision
BECTON DICKINSON INC. (BD)
  SUBSTANTIALLY EQUIVALENT 1

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