QVQ — Extravascular Support For An Arteriovenous Fistula For Vascular Access Class II

FDA Device Classification

FDA product code QVQ covers "Extravascular Support For An Arteriovenous Fistula For Vascular Access", a Class II medical device regulated under 21 CFR 870.4600. Submissions are reviewed by the Cardiovascular panel. Devices under this code are implants. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
QVQ
Device Class
Class II
Regulation Number
870.4600
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
Yes

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K240119laminate medical technologiesVasQFebruary 16, 2024
DEN220026laminate medical technologiesVasQSeptember 26, 2023