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Xvivo Perfusion System (XPS) with Steen Solution Perfusate

FDA PMA

Class III (US FDA PMA)

PMA P180014

by Xvivo Perfusion, Inc.

Identity

Trade Name
XPS™ with Steen Solution™ Perfusate FDA PMA
Generic Name
Normothermic preservation system for transplantation of initially unacceptable donor lungs FDA PMA

Identifiers

PMA Number
P180014 FDA PMA
FDA Product Code
PHO FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
Gastroenterology, Urology FDA PMA
FDA Decision
APPR Approved FDA PMA

The Xvivo Perfusion System (XPS) with Steen Solution Perfusate is a normothermic preservation system for transplantation of initially unacceptable donor lungs. It is indicated for use in flushing and temporary continuous normothermic machine perfusion of initially unacceptable excised donor lungs, during which time the ex vivo function of the lungs can be reassessed for transplantation.

The system is supplied as a perfusion system with Steen Solution Perfusate and is authorized under FDA PMA number P180014. It is intended for use in clinical settings to evaluate and recondition donor lungs prior to transplantation, with all specifications and authorizations as defined in the regulatory data.

Frequently asked questions

What is the Xvivo Perfusion System (XPS) with Steen Solution Perfusate indicated for?

The device is indicated for use in flushing and temporary continuous normothermic machine perfusion of initially unacceptable excised donor lungs, during which time the ex vivo function of the lungs can be reassessed for transplantation.

What regulatory authorization does the Xvivo Perfusion System (XPS) with Steen Solution Perfusate have?

The device has FDA PMA authorization under PMA number P180014, as stated in the AUTHORIZATIONS and pma_number fields of the device data.

Who manufactures the Xvivo Perfusion System (XPS) with Steen Solution Perfusate?

The device is manufactured by XVIVO PERFUSION, INC., as specified in the MANUFACTURER field of the device data.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Xvivo Perfusion, Inc.

Sources (1)

  • FDA PMA P180014 24 fields · synced Sep 18, 2026