BD Nexiva And BD Nexiva Diffusics Closed IV Catheter Systems

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 And Bd Nexiva Diffusics Closed Iv Catheter Systems.

Pre-market Notification Details

• Device ID: K161777
• 510k Number: K161777
• Device Name: BD Nexiva And BD Nexiva Diffusics Closed IV Catheter Systems
• 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 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114
• Product Code: FOZ
• CFR Regulation Number: 880.5200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2016-06-29
• Decision Date: 2016-08-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
50382903835138	K161777	000