The following data is part of a premarket notification filed by Xvivo Perfusion Ab with the FDA for Kidney Assist-transport.
| Device ID | K211333 |
| 510k Number | K211333 |
| Device Name: | KIDNEY ASSIST-transport |
| Classification | System, Perfusion, Kidney |
| Applicant | XVIVO Perfusion AB Mässans Gata 10 Goteborg, SE 41251 |
| Contact | Arjan Van Der Plaats |
| Correspondent | Kathleen Johnson Medical Device Approvals, Inc. 104 E. Harrison Ave. Fairfield, IA 52556 |
| Product Code | KDN |
| CFR Regulation Number | 876.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-03 |
| Decision Date | 2022-01-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08719925460524 | K211333 | 000 |
| 08719925460517 | K211333 | 000 |