Cleared Special

Praxiject 0.9% NaCl

K192414 · Medxl, Inc. · General Hospital

Feb 2020

Decision

162d

Days

Class 2

Risk

About This 510(k) Submission

K192414 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 February 13, 2020, 162 days after receiving the submission on September 4, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K192414 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 04, 2019
Decision Date	February 13, 2020
Days to Decision	162 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.