XVIVO PERFUSION, INC.

US Last updated 23 Oct 2026

Devices: 22
Registries: GUDIDEUDAMEDFDA 510(k)FDA PMAFDA
FDA recalls: 1

Catalogue22

XVIVO Disposable Lung Kit 19046 Ref 19046

Class III FDA UDI Active
PERFADEX Plus® 19800 Ref 19800

Class II FDA UDI
STEEN Solution™ 19004 Ref 19004

Class III FDA UDI Active
PERFADEX Plus (Click US) 19850 Ref 19850

Class II FDA UDI Active
XVIVO Organ Chamber™ 19020 Ref 19020

Class III EUDAMEDFDA UDI Active
XVIVO Perfusion System (XPS™) 19030 Ref 19030

Class III FDA UDI Active
Silicon Tubing Set 19005 Ref 19005

Class II FDA UDI Active
XVIVO Lung Disposables Kit 19035 Ref 19035

Class III FDA UDI
PERFADEX Plus® 19900 Ref 19900

Class II FDA UDI
XVIVO Click Adapter 19024 Ref 19024

Class II FDA UDI Active
XVIVO Disposable Lung Kit 19046 Ref 19046

Class III FDA UDI Active
PERFADEX® Plus 19950 Ref 19950

Class II FDA UDI Active
Perfadex with THAM 19018 Ref 19018

Class II FDA UDI
XVIVO PGM Disposable Sensors™ 19033 Ref 19033

Class III EUDAMEDFDA UDI Active
Perfadex with THAM 19017 Ref 19017

Class II FDA UDI
XVIVO Click Adapter 19125 Ref 19125

Class II FDA UDI Active
XVIVO Lung Cannula Set™ 19022 Ref 19022

Class III EUDAMEDFDA UDI Active
XVIVO Lung Cannula Set II™ 19023 Ref 19023

Class III FDA UDI
Perfadex And Perfadex With Tham Ref K091989

Class II FDA 510(k) Active
KIDNEY ASSIST-transport Ref K211333

Class II FDA 510(k) Active
Perfadex Plus Ref K170826

Class II FDA 510(k) Active
Xvivo Perfusion System (XPS) with Steen Solution Perfusate Ref P180014

Class III FDA PMA Active

FDA recalls1

Recalls this firm reported to the FDA. Device pages show the recalls that name the device or the 510(k)/PMA it was cleared under.

2022
- 8 Apr 2022 Z-1212-2022 Class II Terminated The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed.via FDA establishment XVIVO PERFUSION AB

FDA establishments1

Registered with the FDA under this company group, matched by name.

Xvivo Perfusion Ab Molndal Vastra Gotaland · SE FEI 3007710603

What XVIVO PERFUSION, INC. makes

The company produces systems and consumables for preserving and evaluating donor lungs, including perfusion-based organ chambers, tubing sets, and perfusion solutions. Their portfolio also includes surgical irrigation tubing and disposable sensor kits designed for organ perfusion and monitoring. Examples include perfusion systems paired with Steen Solution perfusate, lung cannula sets, and single-use lung kits for ex vivo organ care.

These devices are regulated under FDA classifications, with some authorised as Class II and others as Class III. They appear in the FDA’s Pre-Market Approval (PMA) and Unique Device Identifier (UDI) registries. The company is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: US
Address: 16080 Table Mountain Pkwy Ste 500, Golden, CO, 80403
FDA FEI number: 3009736925

Catalogue22

XVIVO Disposable Lung Kit 19046 Ref 19046

PERFADEX Plus® 19800 Ref 19800

STEEN Solution™ 19004 Ref 19004

PERFADEX Plus (Click US) 19850 Ref 19850

XVIVO Organ Chamber™ 19020 Ref 19020

XVIVO Perfusion System (XPS™) 19030 Ref 19030

Silicon Tubing Set 19005 Ref 19005

XVIVO Lung Disposables Kit 19035 Ref 19035

PERFADEX Plus® 19900 Ref 19900

XVIVO Click Adapter 19024 Ref 19024

XVIVO Disposable Lung Kit 19046 Ref 19046

PERFADEX® Plus 19950 Ref 19950

Perfadex with THAM 19018 Ref 19018

XVIVO PGM Disposable Sensors™ 19033 Ref 19033

Perfadex with THAM 19017 Ref 19017

XVIVO Click Adapter 19125 Ref 19125

XVIVO Lung Cannula Set™ 19022 Ref 19022

XVIVO Lung Cannula Set II™ 19023 Ref 19023

Perfadex And Perfadex With Tham Ref K091989

KIDNEY ASSIST-transport Ref K211333

Perfadex Plus Ref K170826

Xvivo Perfusion System (XPS) with Steen Solution Perfusate Ref P180014

FDA recalls1

FDA establishments1

What XVIVO PERFUSION, INC. makes

Information