510(k) K213955
K213955 is an FDA 510(k) premarket notification submitted by Becton, Dickinson And Company for the device "0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub". The FDA issued a decision of Substantially Equivalent on Jul 16, 2022. The device falls under product code QTI (Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device), a Class II device regulated under 21 CFR 880.5200. Becton, Dickinson And Company has 329 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 16, 2022
- Date Received
- Dec 17, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device
- Device Class
- Class II
- Regulation Number
- 880.5200
- Review Panel
- HO
- Submission Type
- 510(k)
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.