Data / Medical devices / Sweden / Xvivo Perfusion AB

Xvivo Perfusion AB: FDA-registered device maker in Molndal Vastra Gotaland, Sweden, 1 510(k) clearance and 1 PMA approval

Name: Xvivo Perfusion AB FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Xvivo Perfusion AB is registered with the FDA (registration 3007710603) in Molndal Vastra Gotaland, Sweden. It lists 3 device types. The FDA files 1 510(k) clearance and 1 PMA approval under its listings, the newest dated April 26, 2019. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3007710603
Address: Entreprenorsstraket 10, Molndal Vastra Gotaland, Sweden, 43153
Owner or operator: XVIVO Perfusion AB (10029831)
Roles: Complaint file establishment, Specification developer
First device listed: May 7, 2013
Registered through: 2026
Brand names listed: Perfadex Plus, STEEN Solution, XPS, XPS Disposable Lung Circuit, XVIVO Click Adapter REF 19024, XVIVO Disposable Kit, XVIVO Lung Cannula Set, XVIVO Organ Chamber and more

Devices it lists

Device	Product code	Class	Role	Source
Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs	PHO	3	Complaint file establishment, Specification developer	accessdata.fda.gov
System, Perfusion, Kidney	KDN	2	Complaint file establishment, Specification developer	accessdata.fda.gov
System/Device, Pharmacy Compounding	NEP	2	Complaint file establishment, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 22, 2018	K170826	Perfadex Plus	KDN	Substantially Equivalent	Xvivo Perfusion AB	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
April 26, 2019	P180014	XPS with Steen Solution Perfusate	PHO	13	September 16, 2026	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
April 8, 2022	90143	Class II	Terminated	XVIVO Organ Chamber REF 19020	The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed.	accessdata.fda.gov

Compare with other makers

Updated September 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.