PowerFlow Implantable Apheresis IV Port
K-Number: K191143 · 2019-08-02
ApplicantC.R. Bard, Inc.
Decision Date2019-08-02
Product CodePTD
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
PowerFlow Implantable Apheresis IV Port is a medical device manufactured by C.R. Bard, Inc.. It received FDA 510(k) clearance on 2019-08-02 under approval number K191143. The device is classified under product code PTD. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PowerFlow Implantable Apheresis IV Port?
PowerFlow Implantable Apheresis IV Port is a medical device that received FDA 510(k) clearance on 2019-08-02. It is manufactured by C.R. Bard, Inc.. The 510(k) number is K191143.
When was PowerFlow Implantable Apheresis IV Port approved by the FDA?
PowerFlow Implantable Apheresis IV Port received FDA 510(k) clearance on 2019-08-02, under approval number K191143.
What company makes PowerFlow Implantable Apheresis IV Port?
PowerFlow Implantable Apheresis IV Port is manufactured by C.R. Bard, Inc..
What is the FDA product code for PowerFlow Implantable Apheresis IV Port?
The FDA product code for PowerFlow Implantable Apheresis IV Port is PTD.
Other Devices by C.R. Bard, Inc.
Related Devices (Code: PTD)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.