LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR)— 510(k) K021362

Name: FDA 510(k) clearance K021362
Creator: U.S. Food and Drug Administration
Published: 2003-07-31

Substantially Equivalent

Organ Recovery Systems, Inc.

FDA 510(k) clearance K021362 for LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR), Substantially Equivalent on 2003-07-31. Applicant: Organ Recovery Systems, Inc.. Device class: 2.

Clearance details

Applicant: Organ Recovery Systems, Inc.
Product code: Code KDN
Device class: Class 2
Regulation: 21 CFR 876.5880
Advisory panel: Gastroenterology, Urology
Date received: 2002-04-30
Decision date: 2003-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charleston, SC, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K021362

K-number listed on FDA's recall record

Z-1437-2020 — LKT200 Perfusion Circuit, part of Lifeport Kidney Perfusion Transporter KTR - Product Usage: The circuit is an accessory to LifePort Kidney Perfusion Transporter (KTR) Isolated kidney perfusion and transport system, which is intended to be used for the continuous hypothermic machine perfusion of kidneys for the preservation, transportation and eventual transplantation into a recipient.Class II·Terminated·Organ Recovery Systems, Inc.·20200130

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K021362.

Data sourced from openFDA. This site is unofficial and independent of the FDA.