XVIVO PERFUSION, INC.

FDA Device Registration & Listing · Golden, CO, US · Registration 3009736925

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009736925
FEI Number
3009736925
Entity Name
XVIVO PERFUSION, INC.
City/State/Country
Golden, CO, US
Establishment Address
16080 Table Mountain Pkwy Ste 500, Golden, CO 80403, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
XVIVO Perfusion AB (Owner Number: 10029831)
Owner / Operator Contact Address
Entreprenorsstraket 10, Mölndal, SE-O 43153, SE
Initial Importer Flag
N
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
3028907862 XVIVO PERFUSION, INC. Aurora, CO, US
3021739803 XVIVO BV Groningen, NL
3007710603 XVIVO PERFUSION AB Molndal Vastra Gotaland, SE

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009736925. Last updated year: 2026. Please use registration number 3009736925 when referencing this establishment in official correspondence.
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