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FDA 510(k)

Perfadex Plus

K-Number: K170826 · 2018-06-22

ApplicantXvivo Perfusion AB
Decision Date2018-06-22
Product CodeKDN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Perfadex Plus is a medical device manufactured by Xvivo Perfusion AB. It received FDA 510(k) clearance on 2018-06-22 under approval number K170826. The device is classified under product code KDN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Perfadex Plus?

Perfadex Plus is a medical device that received FDA 510(k) clearance on 2018-06-22. It is manufactured by Xvivo Perfusion AB. The 510(k) number is K170826.

When was Perfadex Plus approved by the FDA?

Perfadex Plus received FDA 510(k) clearance on 2018-06-22, under approval number K170826.

What company makes Perfadex Plus?

Perfadex Plus is manufactured by Xvivo Perfusion AB.

What is the FDA product code for Perfadex Plus?

The FDA product code for Perfadex Plus is KDN.

Other Devices by Xvivo Perfusion AB

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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