Cleared Traditional

0.9% SODIUM CHLORIDE INJECTION USP BD POSIFLUSH FLUSH SYRINGE, SF FLUSH SYRINGE

K121050 · Becton, Dickinson & CO · General Hospital

Feb 2013

Decision

307d

Days

Class 2

Risk

About This 510(k) Submission

K121050 is an FDA 510(k) clearance for the 0.9% SODIUM CHLORIDE INJECTION USP BD POSIFLUSH FLUSH SYRINGE, SF FLUSH SYRINGE, a Saline, Vascular Access Flush (Class II — Special Controls, product code NGT), submitted by Becton, Dickinson & CO (Franklin Lakes, US). The FDA issued a Cleared decision on February 7, 2013, 307 days after receiving the submission on April 6, 2012. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K121050 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 06, 2012
Decision Date	February 07, 2013
Days to Decision	307 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.