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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device percutaneous, implanted, long-term intravascular catheter accessory for catheter position
Regulation Description Percutaneous, implanted, long-term intravascular catheter.
Definition When used in connection with a locator instrument is designed to aid in the placement of central venous catheters by providing real-time information as to the position of the catheter inside the body during the catheter insertion procedure.
Product CodeOMF
Regulation Number 880.5970
Device Class 2


Premarket Reviews
ManufacturerDecision
CORPAK MEDSYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
SONOSITE,INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 2
Total Device Problems 2

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