The following data is part of a premarket notification filed by Vitrolife Sweden Ab with the FDA for Perfadex Solution For Organ Preservation.
| Device ID | K000881 |
| 510k Number | K000881 |
| Device Name: | PERFADEX SOLUTION FOR ORGAN PRESERVATION |
| Classification | System And Accessories, Isolated Heart, Transport And Preservation |
| Applicant | VITROLIFE SWEDEN AB 155 CIDER MILL RD. Ringoes, NJ 08551 |
| Contact | Karl A Posselt |
| Correspondent | Karl A Posselt VITROLIFE SWEDEN AB 155 CIDER MILL RD. Ringoes, NJ 08551 |
| Product Code | MSB |
| CFR Regulation Number | 876.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-20 |
| Decision Date | 2001-03-08 |