The following data is part of a premarket notification filed by Becton Dickinson Infusion Therapy Systems Inc. with the FDA for Bd Nexiva Diffusics Closed Iv Catheter System.
| Device ID | K123734 |
| 510k Number | K123734 |
| Device Name: | BD NEXIVA DIFFUSICS 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 | Kimberly Geisler BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 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 | 2012-12-05 |
| Decision Date | 2013-01-17 |
| Summary: | summary |