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510(k) K191143

Device
PowerFlow Implantable Apheresis IV Port
Applicant
C.R. Bard, Inc.
510(k) number
K191143
Product code
PTD  
Decision
Substantially Equivalent (SESE)
Decision date
2019-08-02
Date received
2019-04-30
Regulation
880.5965
Classification name
Subcutaneous Implanted Apheresis Port
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
Kristen Soodak
Address
605 N. 5600 W. Salt Lake Ciy, UT US 84116 84116

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PTD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K192291TidalPort-AP Implantable Apheresis Vascular Access PortNorfolk Medical Products, Inc.2020-08-20
K163001PowerFlow Apheresis I.V. PortC.R. Bard, Inc.2017-04-17

Legacy Summary#

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FDA Review#

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