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510(k) K162219

Device
CADD® Infusion Disposables Portfolio With NRFit™ Connectors
Applicant
Smiths Medical ASD, Inc.
510(k) number
K162219
Product code
PWH  
Decision
Substantially Equivalent (SESE)
Decision date
2017-07-20
Date received
2016-08-08
Regulation
880.5440
Classification name
Administrations Sets With Neuraxial Connectors
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Wendy J. Kivens
Address
6000 Nathan Ln. N Plymouth MN US 55442 55442

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PWH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K221319BD Alaris™ Pump Epidural Infusion SetCare Fusion2023-07-21
K211649PCEA Syringe SetBaxter Healthcare Corporation2021-11-23
K172592CADD Yellow High Volume Administration Set with NRFit connectorSmiths Medical Asd, Inc.2018-05-17

Legacy Summary#

summary

FDA Review#

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