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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tunneled catheter remover
Regulation Description Percutaneous, implanted, long-term intravascular catheter.
Definition To assist in the removal of tunneled long term catheter cuffs using a minimal invasive technique by seperating the tissue ingrowth cuff from the surrounding tissue. Following seperation of the cuff from the tissue, the catheter can be safely removed from the body.
Product CodeODY
Regulation Number 880.5970
Device Class 2