Xvivo Perfusion, Inc.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Xvivo Perfusion, Inc.”, plus 1 PMA decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PHO | Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs | 1 | 0 |
Review panels
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P180014 | PMA | XPS with Steen Solution Perfusate | 2019-04-26 |
Recalls
openFDA lists no recalls under a recalling firm named Xvivo Perfusion, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Xvivo Perfusion, Inc. is the lead sponsor of 6 device studies on ClinicalTrials.gov (6 active or recruiting). Most recent:
- NCT07556588: XVIVO Heart Transplant Study in Clinical Practice (Recruiting, started 2026-04-15)
- NCT06895070: XVIVO Heart Box (XHB) With Supplemented XVIVO Heart Solution (SXHS) Continued Access Protocol (CAP) (Recruiting, started 2025-07-10)
- NCT06485596: HOPE at Heart (HOPE) of Donor Hearts After Circulatory Death (DCD) Using the XVIVO Heart Assist Transport System. (Active not recruiting, started 2024-08-03)
- NCT05881278: XVIVO Heart Perfusion System (XHPS) With Supplemented XVIVO Heart Solution (SXHS) (Active not recruiting, started 2023-10-10)
- NCT03991923: Non-ischemic Preservation of the Donor Heart in Heart Transplantation (Active not recruiting, started 2020-11-25)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Xvivo Perfusion AB (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Xvivo Perfusion, Inc.?
FDA lists 0 510(k) clearances under the applicant name “Xvivo Perfusion, Inc.”, plus 1 PMA decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Xvivo Perfusion, Inc.?
The most frequent FDA product codes under this applicant name are PHO (Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs, 1).
Next steps
- See all 0 Xvivo Perfusion, Inc. clearances with predicates and recalls
- Run predicate analysis for product code PHO, Xvivo Perfusion, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.