Atlas FDA

BECTON DICKINSON INTELLIPORT SYSTEM

FDA 510(k) clearance K141474 · decided 2014-12-18

Clearance details

K-number
K141474
Device name
BECTON DICKINSON INTELLIPORT SYSTEM
Applicant
Becton, Dickinson & CO
Decision
Substantially Equivalent
Date received
2014-06-03
Decision date
2014-12-18
Days to decision
198 days
Clearance type
Traditional
Product code
PHC
Device class
2
Regulation number
880.5725
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
San Diego, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
BD Intelliport Medication Management System Sensor The system is indicated for use by heal recall (Z-1076-2016)Becton Dickinson & Company2016-03-08