Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access
Medical specialty
Cardiovascular
Device class
2
Regulation number
870.1252
Review panel
CV
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
Definition
Percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access. This device is a single use percutaneous catheter system that creates an arteriovenous fistula in the arm of patients with chronic kidney disease who need hemodialysis.