Cleared Traditional

BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM

K111366 · Becton, Dickinson and Company (BD) · General Hospital

Sep 2011

Decision

137d

Days

Class 2

Risk

About This 510(k) Submission

K111366 is an FDA 510(k) clearance for the BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM, a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by Becton, Dickinson and Company (BD) (Sandy, US). The FDA issued a Cleared decision on September 30, 2011, 137 days after receiving the submission on May 16, 2011. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K111366 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 16, 2011
Decision Date	September 30, 2011
Days to Decision	137 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