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FDA 510(k)

KIDNEY ASSIST-transport

K-Number: K211333 · 2022-01-20

ApplicantXvivo Perfusion AB
Decision Date2022-01-20
Product CodeKDN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

KIDNEY ASSIST-transport 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 2022-01-20 under 510(k) number K211333. 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 KIDNEY ASSIST-transport?

KIDNEY ASSIST-transport is a medical device that received FDA 510(k) clearance on 2022-01-20. The listed applicant is Xvivo Perfusion AB. The 510(k) number is K211333.

When did KIDNEY ASSIST-transport receive FDA 510(k) clearance?

KIDNEY ASSIST-transport received FDA 510(k) clearance on 2022-01-20, under 510(k) number K211333.

Who is the listed applicant for KIDNEY ASSIST-transport?

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 KIDNEY ASSIST-transport?

The FDA product code for KIDNEY ASSIST-transport 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.

K261644Perfadex PlusK170826Perfadex 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.

K261644Perfadex PlusXvivo Perfusion ABK260456VI°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 Lopez

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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