Cleared Traditional

0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE

K003553 · Bd Becton Dickinson Vacutainer Systems Preanalytic · General Hospital

Mar 2001

Decision

124d

Days

Class 2

Risk

About This 510(k) Submission

K003553 is an FDA 510(k) clearance for the 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE, a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on March 21, 2001, 124 days after receiving the submission on November 17, 2000. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K003553 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 17, 2000
Decision Date	March 21, 2001
Days to Decision	124 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	FOZ — Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5200