K161552 is an FDA 510(k) clearance for the 0.9% Sodium Chloride Injection, USP BD PosiFlush SP 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 February 2, 2017, 241 days after receiving the submission on June 6, 2016.
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 | K161552 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 06, 2016 |
| Decision Date | February 02, 2017 |
| Days to Decision | 241 days |
| Submission Type | Special |
| 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. |