Product code QVQ

Device name

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.

Source

FDA openFDA device classification dataset