X°Port Lung Preservation System; X°Port Lung Preservation Solution (K243870)
Description
X°Port Lung Preservation System; X°Port Lung Preservation Solution by Traferox Technologies, Inc., an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243870
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. X°Port Lung Preservation System; X°Port Lung Preservation Solution (K243870) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240650 | LungProtect | Traferox Technologies, Inc. | 2024 |
| K192869 | SherpaPak Lung Preservation System , SherpaPak Liver Transp... | Pragonix Technologies | 2020 |
Trace the full predicate network for K243870
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.