FDA Product Code QVQ: Extravascular Support For An Arteriovenous Fistula For Vascular Access
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.
Leading manufacturers include Laminate Medical Technologies , Ltd..
2
Total
1
Cleared
273d
Avg days
2023
Since
Declining activity -
0 submissions in the last 2 years
vs 2 in the prior period
FDA 510(k) Cleared Extravascular Support For An Arteriovenous Fistula For Vascular Access Devices (Product Code QVQ)
2 devices
Cleared
Feb 16, 2024
VasQ
Laminate Medical Technologies , Ltd.
Cardiovascular
31d
Not Cleared
Sep 26, 2023
VasQ
Laminate Medical Technologies , Ltd.
Cardiovascular
515d
About Product Code QVQ - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code QVQ since 2023, with 1 receiving FDA clearance (average review time: 273 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.