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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, hemodialysis, non-implanted, ultrafiltration, for peripheral use
Regulation Description Blood access device and accessories.
Definition Dual lumen, non-implanted, peripheral access catheters are inserted in the peripheral arm vein and are indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload.
Product CodeNQJ
Regulation Number 876.5540
Device Class 2


Premarket Reviews
ManufacturerDecision
CHF SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 2

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