510(k) K250884

Device: 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe
Applicant: Becton, Dickinson and Company
510(k) number: K250884
Product code: NGT
Decision: Substantially Equivalent (SESE)
Decision date: 2025-12-02
Date received: 2025-03-24
Regulation: 880.5200
Classification name: Saline, Vascular Access Flush
Medical specialty: General Hospital
Review panel: General Hospital
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: N

Applicant Contact#

Contact: Michael Pacelli
Address: 1 Becton Dr. Franklin Lakes NJ US 07417 07417

FDA Registration Numbers#

Source Documents#

510(k) summary PDF