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FDA 510(k)

xevonta dialyzer

K-Number: K143482 · 2016-03-01

ApplicantB. Braun Avitum AG
Decision Date2016-03-01
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

xevonta dialyzer is a medical device manufactured by B. Braun Avitum AG. It received FDA 510(k) clearance on 2016-03-01 under approval number K143482. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the xevonta dialyzer?

xevonta dialyzer is a medical device that received FDA 510(k) clearance on 2016-03-01. It is manufactured by B. Braun Avitum AG. The 510(k) number is K143482.

When was xevonta dialyzer approved by the FDA?

xevonta dialyzer received FDA 510(k) clearance on 2016-03-01, under approval number K143482.

What company makes xevonta dialyzer?

xevonta dialyzer is manufactured by B. Braun Avitum AG.

What is the FDA product code for xevonta dialyzer?

The FDA product code for xevonta dialyzer is KDI.

Other Devices by B. Braun Avitum AG

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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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