BD Nexiva Closed IV Catheter System

Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

Becton Dickinson Infusion Therapy Systems Inc.

The following data is part of a premarket notification filed by Becton Dickinson Infusion Therapy Systems Inc. with the FDA for Bd Nexiva Closed Iv Catheter System.

Pre-market Notification Details

• Device ID: K183399
• 510k Number: K183399
• Device Name: BD Nexiva Closed IV Catheter System
• Classification: Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
• Applicant: Becton Dickinson Infusion Therapy Systems Inc. 9450 South State Street Sandy, UT 84070
• Contact: Kimberly Geisler
• Correspondent: Mark Job; REGULATORY TECHNOLOGY SERVICES, LLC 1394 25TH STREET, NW Buffalo, MN 55313
• Product Code: FOZ
• CFR Regulation Number: 880.5200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2018-12-07
• Decision Date: 2019-03-20

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20801741222881	K183399	000
20801741222478	K183399	000
10801741222464	K183399	000
20801741222454	K183399	000
10801741222440	K183399	000