510(k) K153481
K153481 is an FDA 510(k) premarket notification submitted by Becton, Dickinson and Company for the device "0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe". The FDA issued a decision of Substantially Equivalent on April 4, 2016. The device falls under product code NGT (Saline, Vascular Access Flush), a Class II device regulated under 21 CFR 880.5200. Becton, Dickinson and Company has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 4, 2016
- Date Received
- December 3, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Saline, Vascular Access Flush
- Device Class
- Class II
- Regulation Number
- 880.5200
- Review Panel
- HO
- Submission Type
Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use.