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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 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 2017-04-17 under 510(k) 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. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K163001.

When did PowerFlow Apheresis I.V. Port receive FDA 510(k) clearance?

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

Who is the listed applicant for PowerFlow Apheresis I.V. 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 Apheresis I.V. Port?

The FDA product code for PowerFlow Apheresis I.V. 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.

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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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