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FDA 510(k)

PowerFlow Apheresis I.V. Port

K-Number: K163001 · 2017-04-17

ApplicantC.R. Bard, Inc.
Decision Date2017-04-17
Product CodePTD
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PowerFlow Apheresis I.V. Port is a medical device manufactured by C.R. Bard, Inc.. It received FDA 510(k) clearance on 2017-04-17 under approval number K163001. 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 Apheresis I.V. Port?

PowerFlow Apheresis I.V. Port is a medical device that received FDA 510(k) clearance on 2017-04-17. It is manufactured by C.R. Bard, Inc.. The 510(k) number is K163001.

When was PowerFlow Apheresis I.V. Port approved by the FDA?

PowerFlow Apheresis I.V. Port received FDA 510(k) clearance on 2017-04-17, under approval number K163001.

What company makes PowerFlow Apheresis I.V. Port?

PowerFlow Apheresis I.V. Port is manufactured by C.R. Bard, Inc..

What is the FDA product code for PowerFlow Apheresis I.V. Port?

The FDA product code for PowerFlow Apheresis I.V. Port is PTD.

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Related Devices (Code: PTD)

K191143PowerFlow Implantable Apheresis IV PortC.R. Bard, Inc. K192291TidalPort-AP Implantable Apheresis Vascular Access PortNorfolk Medical Products, Inc.

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.

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