Class Class II
TransForm McCarthy Mitral Annuloplasty Ring (TF) (K250859)
Description
TransForm McCarthy Mitral Annuloplasty Ring (TF) by Genesee Biomedical, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250859
Clearance Date2025-07-25
Clearance TypeTraditional
Product CodeKRH
Regulation Number870.3800
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250859
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. TransForm McCarthy Mitral Annuloplasty Ring (TF) (K250859) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232599 | TransForm McCarthy Mitral Annuloplasty Ring (TF) | Genesee Biomedical, Inc. | 2024 |
Trace the full predicate network for K250859
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.