Cleared Traditional

Normal Saline Flush

K150143 · Nurse Assist, Inc. · General Hospital

Aug 2015

Decision

221d

Days

Class 2

Risk

About This 510(k) Submission

K150143 is an FDA 510(k) clearance for the Normal Saline Flush, a Saline, Vascular Access Flush (Class II — Special Controls, product code NGT), submitted by Nurse Assist, Inc. (Haltom City, US). The FDA issued a Cleared decision on August 31, 2015, 221 days after receiving the submission on January 22, 2015. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K150143 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 22, 2015
Decision Date	August 31, 2015
Days to Decision	221 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.