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510(k) Data Aggregation
K Number
K990229Device Name
HPA PORTABLE KIDNEY PRESERVATION SYSTEM, MODEL J-1000-1
Manufacturer
Date Cleared
1999-11-04
(283 days)
Product Code
Regulation Number
876.5880Why did this record match?
Applicant Name (Manufacturer) :
JUSTEC MEDICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The HPA Portable Kidney Transport System is intended for preserving and transporting kidneys for transplant.
The HPA Portable Kidney Preservation System, Model J-1000-1 is to be used when prescribed by a physician for the use of storing and preserving a human kidney
Device Description
The HPA Portable Kidney Transport System is a patented, self contained renal preservation system that provides the benefits of machine perfusion with a simplified perfusion circuit. The device provides low flow pulsatile perfusion with regulated arterial pressure limits. Audio and visual alarms are provided for over pressure, over temperature, pump failure, tubing failure, and battery failure conditions.
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