Cleared Traditional

Pre-Filled Normal Saline Flush Syringe

K223584 · Anhui Tianyang Pharmaceutical Co., Ltd. · General Hospital

Aug 2023

Decision

254d

Days

Class 2

Risk

About This 510(k) Submission

K223584 is an FDA 510(k) clearance for the Pre-Filled Normal Saline Flush Syringe, a Saline, Vascular Access Flush (Class II — Special Controls, product code NGT), submitted by Anhui Tianyang Pharmaceutical Co., Ltd. (Tianchang, CN). The FDA issued a Cleared decision on August 12, 2023, 254 days after receiving the submission on December 1, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K223584 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 01, 2022
Decision Date	August 12, 2023
Days to Decision	254 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.