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NGT

Saline, Vascular Access Flush

Product code
NGT
Device name
Saline, Vascular Access Flush
Device class
Class 2
21 CFR
21 CFR 880.5200
Medical specialty
General Hospital
Marketing pathway
510(K)
510(k) clearances (last 3 years)
4
Summaries archived here
4 (direct download)
510(k) clearances (all years, FDA)
40 (all years; only the last 3 years are listed here)

FDA classification definition

Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (4)

Last three years. Most recent: 2025-12-02.

NumberDecision dateApplicantDevice nameSummary
K2508842025-12-02Becton, Dickinson and Company0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ …PDF
K2336232024-02-27Medxl, Inc.Praxiject™ SP 0.9% NaClPDF
K2317242023-11-09Spm Medicare Pvt. , Ltd.Flush Syringe (Prefilled 0.9% normal saline solution…PDF
K2313632023-09-27Hantech Medical Device Co., Ltd.Hantech Pre-filled 0.9% Normal Saline Flush Syringes…PDF

4 summaries are archived here for direct download.

Official FDA classification page: NGT
Classification and pathway per current FDA publications. Data from openFDA (CC0).