Cleared Traditional

K090882 - FLUSH SYRINGE FILLED WITH 0.9% SODIUM CHLORIDE
(FDA 510(k) Clearance)

K090882 · Hospira, Inc. · General Hospital

Apr 2010

Decision

388d

Days

Class 2

Risk

K090882 is an FDA 510(k) clearance for the FLUSH SYRINGE FILLED WITH 0.9% SODIUM CHLORIDE, a Saline, Vascular Access Flush (Class II — Special Controls, product code NGT), submitted by Hospira, Inc. (Lake Forest, US). The FDA issued a Cleared decision on April 23, 2010, 388 days after receiving the submission on March 31, 2009. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K090882 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 31, 2009
Decision Date	April 23, 2010
Days to Decision	388 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.