NGT — Saline, Vascular Access Flush Class II

FDA Device Classification

Classification Details

Product Code
NGT
Device Class
Class II
Regulation Number
880.5200
Submission Type
Review Panel
HO
Medical Specialty
General Hospital
Implant
No

Definition

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K250884becton, dickinson and0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP SyringeDecember 2, 2025
K233623medxlPraxiject™ SP 0.9% NaClFebruary 27, 2024
K231724spm medicare pvt.Flush Syringe (Prefilled 0.9% normal saline solution)November 9, 2023
K231363hantech medical device coHantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005,September 27, 2023
K223584anhui tianyang pharmaceutical coPre-Filled Normal Saline Flush SyringeAugust 12, 2023
K230756anhui tiankang medical technology coTK Pre-Filled Normal Saline Flush SyringeAugust 12, 2023
K231161becton, dickinson and0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush SyringeJuly 21, 2023
K231754medxlPraxiject™ 0.9% NaClJuly 13, 2023
K214080pentaferte italiaPentaflushJuly 20, 2022
K220060jiangsu caina medical coPre-filled Syringe with SalineJune 10, 2022
K213522amsino internationalAMSafe Pre-Filled Normal Saline Flush SyringeMarch 22, 2022
K201286nurse assist0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0August 11, 2020
K192414medxlPraxiject 0.9% NaClFebruary 13, 2020
K191378medline industries0.9% Sodium Chloride Injection, USP, Pre-filled COP SyringeSeptember 15, 2019
K183473amsino internationalAMSafe(R) Pre-Filled Normal Saline Flush SyringeJuly 12, 2019
K173348medline industries0.9% Sodium Chloride Injection, USPJune 21, 2018
K171109medxlPraxiject 0.9% NaClDecember 21, 2017
K161552becton, dickinson and0.9% Sodium Chloride Injection, USP BD PosiFlush SP SyringeFebruary 2, 2017
K153481becton, dickinson and0.9% Sodium Chloride Injection, USP BD PosiFlush SF SyringeApril 4, 2016
K150143nurse assistNormal Saline FlushAugust 31, 2015