Cleared Traditional

0.9% Sodium Chloride Injection, USP BD PosiFlush? SF Saline Flush Syringe

K231161 · Becton, Dickinson and Company · General Hospital

Jul 2023

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K231161 is an FDA 510(k) clearance for the 0.9% Sodium Chloride Injection, USP BD PosiFlush? SF Saline Flush Syringe, 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 review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K231161 FDA.gov
FDA Decision	Cleared 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

Device Classification

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.