Class Class II
VersaCross Connect™ Transseptal Dilator (K251325)
Description
VersaCross Connect™ Transseptal Dilator by Baylis Medical Company, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251325
Clearance Date2025-05-29
Clearance TypeSpecial
Product CodeDRE
Regulation Number870.1310
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251325
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. VersaCross Connect™ Transseptal Dilator (K251325) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241720 | VersaCross Connect Transseptal Dilator | Baylis Medical Company, Inc. | 2024 |
Trace the full predicate network for K251325
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.