The following data is part of a premarket notification filed by Xvivo Perfusion Ab with the FDA for Perfadex Plus.
| Device ID | K170826 |
| 510k Number | K170826 |
| Device Name: | Perfadex Plus |
| Classification | System, Perfusion, Kidney |
| Applicant | XVIVO Perfusion AB Goteborg, SE |
| Contact | Kathleen Johnson |
| Correspondent | Kathleen Johnson Medical Device Approvals, Inc. P.O. Box 421 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 | 2017-03-20 |
| Decision Date | 2018-06-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350069520296 | K170826 | 000 |
| 07350069520289 | K170826 | 000 |
| 07350069520241 | K170826 | 000 |
| 07350069520234 | K170826 | 000 |