The following data is part of a premarket notification filed by Transmedics, Inc. with the FDA for Ocs Lung Donor Flush Set.
| Device ID | K222535 |
| 510k Number | K222535 |
| Device Name: | OCS Lung Donor Flush Set |
| Classification | System And Accessories, Isolated Heart, Transport And Preservation |
| Applicant | TransMedics, Inc. 200 Minuteman Road Suite 302 Andover, MA 01810 |
| Contact | Miriam Provost |
| Correspondent | Miriam Provost TransMedics, Inc. 200 Minuteman Road Suite 302 Andover, MA 01810 |
| Product Code | MSB |
| CFR Regulation Number | 876.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-08-22 |
| Decision Date | 2022-11-18 |