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FDA 510(k)

Perfadex Plus

K-Number: K261644 · 2026-07-23

ApplicantXvivo Perfusion AB
Decision Date2026-07-23
Product CodeKDN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Perfadex Plus is the device name listed in this FDA 510(k) record. The listed applicant is Xvivo Perfusion AB. It received FDA 510(k) clearance on 2026-07-23 under 510(k) number K261644. 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 2026-07-23. The listed applicant is Xvivo Perfusion AB. The 510(k) number is K261644.

When did Perfadex Plus receive FDA 510(k) clearance?

Perfadex Plus received FDA 510(k) clearance on 2026-07-23, under 510(k) number K261644.

Who is the listed applicant for Perfadex Plus?

The FDA 510(k) record lists Xvivo Perfusion AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Perfadex Plus?

The FDA product code for Perfadex Plus is KDN.

Other records listing Xvivo Perfusion AB as applicant

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.

K211333KIDNEY ASSIST-transportK170826Perfadex Plus

Related Devices (Code: KDN)

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.

K260456VI°Port™ Liver Preservation SystemTraferox Technologies, Inc.K254305BAROguard Donor Lung Preservation SystemParagonix Technologies, Inc.K243618EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250)Bridge TO LifeK243870X°Port Lung Preservation System; X°Port Lung Preservation SolutionTraferox Technologies, Inc.K243998DCX Disposable Cassette (DCX)Institut Geroges LopezK243384Belzer UW® Cold Storage Solution (BTLBUW-001)Bridge TO Life

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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