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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device extravascular support for an arteriovenous fistula for vascular access
Definition This device is a permanent implant which is surgically placed outside and/or around an artery and/or vein to provide external support to arteriovenous fistulas created for vascular access by means of vascular surgery.
Product CodeQVQ
Regulation Number 870.4600
Device Class 2


Premarket Reviews
ManufacturerDecision
LAMINATE MEDICAL TECHNOLOGIES LTD.
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 1

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