DeviceClearance

Product code QVQ— Cardiovascular

VasQ

Classification name
Extravascular Support For An Arteriovenous Fistula For Vascular Access
Device class
Class 2
Regulation
21 CFR 870.4600
Advisory panel
Cardiovascular
Total cleared
2
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code QVQ under 21 CFR 870.4600, via openFDA

Market context for product code QVQ

FDA has cleared 2 devices under product code QVQ between 2023 and 2024, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QVQ

Recent clearances under product code QVQ

Data sourced from openFDA. This site is unofficial and independent of the FDA.