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FDA 510(k)

PERFADEX AND PERFADEX WITH THAM

K-Number: K091989 · 2010-10-01

ApplicantXvivo Perfusion AB
Decision Date2010-10-01
Product CodeKDN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PERFADEX AND PERFADEX WITH THAM 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 2010-10-01 under 510(k) number K091989. 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 AND PERFADEX WITH THAM?

PERFADEX AND PERFADEX WITH THAM is a medical device that received FDA 510(k) clearance on 2010-10-01. The listed applicant is Xvivo Perfusion AB. The 510(k) number is K091989.

When did PERFADEX AND PERFADEX WITH THAM receive FDA 510(k) clearance?

PERFADEX AND PERFADEX WITH THAM received FDA 510(k) clearance on 2010-10-01, under 510(k) number K091989.

Who is the listed applicant for PERFADEX AND PERFADEX WITH THAM?

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 AND PERFADEX WITH THAM?

The FDA product code for PERFADEX AND PERFADEX WITH THAM is KDN.

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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 PlusK211333KIDNEY 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.

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

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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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