The following data is part of a premarket notification filed by Becton Dickinson Infusion Therapy Systems, Inc. with the FDA for Nexiva Closed Iv Catheter System.
Device ID | K032843 |
510k Number | K032843 |
Device Name: | 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 ST. Sandy, UT 84070 |
Contact | Leslie Wood |
Correspondent | Leslie Wood BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. 9450 SOUTH STATE ST. 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 | 2003-09-11 |
Decision Date | 2004-02-27 |
Summary: | summary |