K211314 is an FDA 510(k) clearance for the OCS Lung Solution. This device is classified as a System And Accessories, Isolated Heart, Transport And Preservation (Class II - Special Controls, product code MSB).
Submitted by TransMedics, Inc. (Andover, US). The FDA issued a Cleared decision on July 29, 2021, 90 days after receiving the submission on April 30, 2021.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5880.
| 510(k) Number | K211314 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 30, 2021 |
| Decision Date | July 29, 2021 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | MSB - System And Accessories, Isolated Heart, Transport And Preservation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5880 |