FDA Product Code QTI: Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device
Prefilled Saline Flush Syringe With An Integrated Disinfection Unit Is Intended To Be Used As A Disinfection Cleaner For Needleless Access Devices Attached To Indwelling Vascular Access Devices (vads) And Flushing Of These Vads.
Leading manufacturers include Becton, Dickinson and Company.
1
Total
1
Cleared
211d
Avg days
2022
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device Devices (Product Code QTI)
1 devices
About Product Code QTI - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code QTI since 2022, with 1 receiving FDA clearance (average review time: 211 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.