Cleared Traditional

AMSafe Pre-Filled Normal Saline Flush Syringe

K213522 · Amsino International, Inc. · General Hospital

Mar 2022

Decision

139d

Days

Class 2

Risk

About This 510(k) Submission

K213522 is an FDA 510(k) clearance for the AMSafe Pre-Filled Normal Saline Flush Syringe, a Saline, Vascular Access Flush (Class II — Special Controls, product code NGT), submitted by Amsino International, Inc. (Pomona, US). The FDA issued a Cleared decision on March 22, 2022, 139 days after receiving the submission on November 3, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K213522 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 03, 2021
Decision Date	March 22, 2022
Days to Decision	139 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.