Data / Medical devices / United States / Xvivo Perfusion, Inc.
Xvivo Perfusion, Inc.: FDA-registered device maker in Aurora, CO, United States, 1 PMA approval
Xvivo Perfusion, Inc. is registered with the FDA (registration 3028907862) in Aurora, CO, United States. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated April 26, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3028907862
- Address
- 3250 Quentin Street, Suite #134, Aurora, CO, United States, 80011
- Owner or operator
- XVIVO Perfusion AB (10029831)
- Roles
- Manufacturer
- First device listed
- November 23, 2019
- Registered through
- 2026
- Brand names listed
- STEEN Solution, XPS, XPS Disposable Lung Circuit, XVIVO Disposable Kit, XVIVO Lung Cannula Set, XVIVO Organ Chamber, XVIVO PGM
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs | PHO | 3 | Manufacturer | 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 |
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.