The following data is part of a premarket notification filed by Transmedics, Inc. with the FDA for Ocs Lung Solution.
| Device ID | K211314 |
| 510k Number | K211314 |
| Device Name: | OCS Lung Solution |
| Classification | System And Accessories, Isolated Heart, Transport And Preservation |
| Applicant | TransMedics, Inc. 200 Minuteman Road, Suite 302 Andover, MA 01810 |
| Contact | Miriam Provost |
| Correspondent | Christy Foreman Biologics Consulting Group, Inc. 1555 King Street, Suite 300 Alexandria, VA 22314 |
| Product Code | MSB |
| CFR Regulation Number | 876.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-30 |
| Decision Date | 2021-07-29 |