Cleared Traditional

Praxiject? SP 0.9% NaCl

K233623 · Medxl, Inc. · General Hospital

Feb 2024

Decision

106d

Days

Class 2

Risk

About This 510(k) Submission

K233623 is an FDA 510(k) clearance for the Praxiject? SP 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 27, 2024, 106 days after receiving the submission on November 13, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K233623 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 13, 2023
Decision Date	February 27, 2024
Days to Decision	106 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.