K213955 is an FDA 510(k) clearance for the 0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub. This device is classified as a Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device (Class II - Special Controls, product code QTI).
Submitted by Becton, Dickinson and Company (Franklin Lakes, US). The FDA issued a Cleared decision on July 16, 2022, 211 days after receiving the submission on December 17, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5200. 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..
| 510(k) Number | K213955 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 17, 2021 |
| Decision Date | July 16, 2022 |
| Days to Decision | 211 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | QTI — Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5200 |
| 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. |