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FDA 510(k)

LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR)

K-Number: K021362 · 2003-07-31

ApplicantOrgan Recovery Systems, Inc.
Decision Date2003-07-31
Product CodeKDN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR) is the device name listed in this FDA 510(k) record. The listed applicant is Organ Recovery Systems, Inc.. It received FDA 510(k) clearance on 2003-07-31 under 510(k) number K021362. 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 LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR)?

LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR) is a medical device that received FDA 510(k) clearance on 2003-07-31. The listed applicant is Organ Recovery Systems, Inc.. The 510(k) number is K021362.

When did LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR) receive FDA 510(k) clearance?

LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR) received FDA 510(k) clearance on 2003-07-31, under 510(k) number K021362.

Who is the listed applicant for LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR)?

The FDA 510(k) record lists Organ Recovery Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR)?

The FDA product code for LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR) is KDN.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Organ Recovery Systems, Inc. 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.

K091656SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2LK022391MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIIONK013575KPS-I, THE KIDNEY PERFUSION SOLUTION

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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