Extravascular Support For An Arteriovenous Fistula For Vascular Access
Medical specialty
Cardiovascular
Device class
2
Regulation number
870.4600
Review panel
CV
Implant
Y
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
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.