The following data is part of a premarket notification filed by Becton Dickinson And Company (bd) with the FDA for Bd Nexiva Diffusics Closed Iv Catheter System.
Device ID | K111366 |
510k Number | K111366 |
Device Name: | BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM |
Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
Applicant | BECTON DICKINSON AND COMPANY (BD) 9450 SOUTH STATE STREET Sandy, UT 84070 |
Contact | Rachel Leblanc |
Correspondent | Rachel Leblanc BECTON DICKINSON AND COMPANY (BD) 9450 SOUTH STATE STREET Sandy, UT 84070 |
Product Code | FOZ |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-05-16 |
Decision Date | 2011-09-30 |
Summary: | summary |