K231161 is an FDA 510(k) clearance for the 0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush Syringe. This device is classified as a Saline, Vascular Access Flush (Class II - Special Controls, product code NGT).
Submitted by Becton, Dickinson and Company (Franklin Lakes, US). The FDA issued a Cleared decision on July 21, 2023, 88 days after receiving the submission on April 24, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5200. Enhance The Performance Of Intravascular Catheters, To Maintain Patency Of The Vascular Catheter When It Is Not In Use..
| 510(k) Number | K231161 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 24, 2023 |
| Decision Date | July 21, 2023 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | NGT — Saline, Vascular Access Flush |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5200 |
| Definition | Enhance The Performance Of Intravascular Catheters, To Maintain Patency Of The Vascular Catheter When It Is Not In Use. |