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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2019-08-02 under 510(k) 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. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K191143.

When did PowerFlow Implantable Apheresis IV Port receive FDA 510(k) clearance?

PowerFlow Implantable Apheresis IV Port received FDA 510(k) clearance on 2019-08-02, under 510(k) number K191143.

Who is the listed applicant for PowerFlow Implantable Apheresis IV Port?

The FDA 510(k) record lists C.R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PowerFlow Implantable Apheresis IV Port?

The FDA product code for PowerFlow Implantable Apheresis IV Port is PTD.

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Related Devices (Code: PTD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K192291TidalPort-AP Implantable Apheresis Vascular Access PortNorfolk Medical Products, Inc.K163001PowerFlow Apheresis I.V. PortC.R. Bard, 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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