# K251325: VersaCross Connect™ Transseptal Dilator

- Pathway: 510(k) (Special)
- Applicant: Baylis Medical Company, Inc.
- Decided: May 29, 2025 after 30 days
- Product code: DRE (Dilator, Vessel, For Percutaneous Catheterization)
- Device class: 2
- Regulation: 21 CFR 870.1310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K013919 (2002). 6 ancestors in all.
No later device cites it as a predicate yet.
1 of 7 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241720: VersaCross Connect™ Transseptal Dilator, Baylis Medical Company, Inc. (2024) Summary page 6.

## Indications for use
The VersaCross Connect Transseptal Dilator is indicated for use in procedures where access to the left atrium via the transseptal technique is desired.

Source page: https://510kreport.com/device/K251325
Methodology: https://510kreport.com/methodology