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FDA 510(k)

KIDNEY PERFUSION MACHINE

K-Number: K864140 · 1987-03-05

ApplicantAdvanced Equipment Development, Inc.
Decision Date1987-03-05
Product CodeKDN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

KIDNEY PERFUSION MACHINE is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Equipment Development, Inc.. It received FDA 510(k) clearance on 1987-03-05 under 510(k) number K864140. 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 PERFUSION MACHINE?

KIDNEY PERFUSION MACHINE is a medical device that received FDA 510(k) clearance on 1987-03-05. The listed applicant is Advanced Equipment Development, Inc.. The 510(k) number is K864140.

When did KIDNEY PERFUSION MACHINE receive FDA 510(k) clearance?

KIDNEY PERFUSION MACHINE received FDA 510(k) clearance on 1987-03-05, under 510(k) number K864140.

Who is the listed applicant for KIDNEY PERFUSION MACHINE?

The FDA 510(k) record lists Advanced Equipment Development, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KIDNEY PERFUSION MACHINE?

The FDA product code for KIDNEY PERFUSION MACHINE is KDN.

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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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