BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM


Device Classification Name

catheter,intravascular,therapeutic,short-term less than 30 days

510(k) Number K111366
Device Name BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM
Applicant
BECTON DICKINSON AND COMPANY (BD)
9450 south state street
sandy, 
UT 
84070

Applicant Contact rachel leblanc
Correspondent
BECTON DICKINSON AND COMPANY (BD)
9450 south state street
sandy, 
UT 
84070

Correspodent Contact rachel leblanc
Regulation Number 880.5200
Classification Product Code
FOZ  
Date Received 05/16/2011
Decision Date 09/30/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No