Cleared Special

Praxiject? 0.9% NaCl

K231754 · Medxl, Inc. · General Hospital

Jul 2023

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K231754 is an FDA 510(k) clearance for the Praxiject? 0.9% NaCl, a Saline, Vascular Access Flush (Class II — Special Controls, product code NGT), submitted by Medxl, Inc. (Pointe-Claire, CA). The FDA issued a Cleared decision on July 13, 2023, 28 days after receiving the submission on June 15, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K231754 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 15, 2023
Decision Date	July 13, 2023
Days to Decision	28 days
Submission Type	Special
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.