QTI — Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device Class II
FDA product code QTI covers "Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device", a Class II medical device regulated under 21 CFR 880.5200. Submissions are reviewed by the General Hospital panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QTI
- Device Class
- Class II
- Regulation Number
- 880.5200
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Definition
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K213955 | becton, dickinson and | 0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub | July 16, 2022 |