Cleared Traditional

Praxiject 0.9% NaCl

K171109 · Medxl, Inc. · General Hospital

Dec 2017

Decision

251d

Days

Class 2

Risk

About This 510(k) Submission

K171109 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 December 21, 2017, 251 days after receiving the submission on April 14, 2017. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K171109 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 14, 2017
Decision Date	December 21, 2017
Days to Decision	251 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.