Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3028907862

FEI Number

3028907862

Entity Name

XVIVO PERFUSION, INC.

City/State/Country

Aurora, CO, US

Establishment Address

3250 Quentin Street, Suite #134, Aurora, CO 80011, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

XVIVO Perfusion AB (Owner Number: 10029831)

Owner / Operator Contact Address

Entreprenorsstraket 10, Mölndal, SE-O 43153, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P180014

All Registered Proprietary Names

XPS Disposable Lung Circuit XVIVO Organ Chamber XVIVO PGM STEEN Solution XVIVO Disposable Kit XPS XVIVO Lung Cannula Set

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PHO	Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs	Unknown	Class 3	N/A	2019-11-23

Official Correspondent

Katrin Gisselfalt

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

XVIVO Perfusion AB

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3021739803	XVIVO BV	Groningen, NL
3009736925	XVIVO PERFUSION, INC.	Golden, CO, US
3007710603	XVIVO PERFUSION AB	Molndal Vastra Gotaland, SE

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1220477	ISOMEDIX OPERATIONS INC.	Northborough, MA, US
3012102437	Synergy Health AST, LLC	Petaluma, CA, US
3009736925	XVIVO PERFUSION, INC.	Golden, CO, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3028907862. Last updated year: 2026. Please use registration number 3028907862 when referencing this establishment in official correspondence.