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510(k) Data Aggregation
K Number
K211333Device Name
KIDNEY ASSIST-transport
Manufacturer
XVIVO Perfusion AB
Date Cleared
2022-01-20
(262 days)
Product Code
KDN
Regulation Number
876.5880Why did this record match?
Applicant Name (Manufacturer) :
XVIVO Perfusion AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KIDNEY ASSIST-transport is intended to be used for the pulsatile hypothermic oxygenated machine perfusion of kidneys for the preservation, transport and eventual transplantation into a recipient.
Device Description
The KIDNEY ASSIST-transport system of Organ Assist Products B.V. is a portable pump system that continuously allows hypothermic pulsatile perfusion of donor kidneys with oxygenated preservation solution during transport from donor to recipient in transplantation procedures. The system consists of the reusable KIDNEY ASSISTtransport device and a disposable KIDNEY ASSIST-transport perfusion set. The characteristics of the KIDNEY ASSIST-transport are:
- Pulsatile oxygenated hypothermic machine perfusion of donor kidneys ●
- Transportable hypothermic machine perfusion technique
- Hypothermic preservation and reconditioning device
- Improved preservation compared to cold storage in DBD, ECD and DCD
- Easy to install disposable perfusion set
The KIDNEY ASSIST-transport device is a thermo isolated enclosure wherein the kidneys are cooled passively by ice and a separate compartment holding the electronics, batteries and a dedicated medical oxygen cylinder. The device has sufficient battery power, holds enough oxygen and ice for an application period of 24 hours of hypothermic oxygenated perfusion. Pulsatile perfusion is generated by a rotary pump driven by an electromotor and is pressure controlled. User-friendly firmware allows the user to change perfusion parameters. Settings and results of the perfusion measurements are numerically displayed on the top of the enclosure. The single-use disposable KIDNEY ASSIST-transport perfusion set contains an easy to install preassembled perfusion cartridge for use in combination with the KIDNEY ASSIST-transport device. The purpose of the KIDNEY ASSIST-transport Perfusion Set is to perfuse human organs to be transplanted with an approved pump perfusion solution. Its set contains a reservoir, kidney holder, cannula, oxygenator, pump head, pressure sensor and compatible tubing. Pulsatile perfusion is maintained by the centrifugal pump head, pulsating the perfusion solution from the reservoir through the oxygenator to the kidney holder in the reservoir. Oxygenation is performed by the hollow fiber membrane oxygenator which facilitates the gas exchange with the perfusion solution. All kidneys will be perfused with University of Wisconsin Machine Perfusion Solution (UW-MP).
KIDNEY ASSIST-transport allows transportable machine perfusion to bridge the timespan between procurement and transplantation of kidneys.
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K Number
K170826Device Name
Perfadex Plus
Manufacturer
XVIVO Perfusion AB
Date Cleared
2018-06-22
(459 days)
Product Code
KDN
Regulation Number
876.5880Why did this record match?
Applicant Name (Manufacturer) :
XVIVO Perfusion AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Perfadex Plus is indicated for the flushing, static cold storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient.
Device Description
Perfadex® Plus is a pre-buffered, extracellular solution of dextran 40 containing calcium used for rapid cooling, perfusion and storage of lungs in connection with transplantation.
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K Number
K091989Device Name
PERFADEX AND PERFADEX WITH THAM
Manufacturer
XVIVO PERFUSION AB
Date Cleared
2010-10-01
(456 days)
Product Code
KDN
Regulation Number
876.5880Why did this record match?
Applicant Name (Manufacturer) :
XVIVO PERFUSION AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Perfadex® Solution for Lung Perfusion is indicated for the flushing, storage and transportation of isolated lungs after removal from the donor, in preparation for eventual transplantation into a recipient
Device Description
Perfadex® and Perfadex® with THAM is a colloid based "extracellular" low potassium electrolyte solution for rapid cooling, perfusion and storage of lungs in connection with transplantation
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