The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd Nexiva Diffusics Closed Iv Catheter System.
Device ID | K170283 |
510k Number | K170283 |
Device Name: | BD Nexiva Diffusics Closed IV Catheter System |
Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
Applicant | Becton, Dickinson And Company 9450 South State Street Sandy, UT 84070 |
Contact | Amy Honey |
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 | 2017-01-30 |
Decision Date | 2017-02-28 |
Summary: | summary |