Baylis Medical Company, Inc. · Class II · Cleared May 29, 2025
| K-number | K251325 |
| Device name | VersaCross Connect Transseptal Dilator |
| Applicant | Baylis Medical Company, Inc. |
| Product code | DRE |
| Device class | Class II |
| Decision date | May 29, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 870.1310 |
The VersaCross Connect Transseptal Dilator is a single-use, sterile device designed to safely dilate the atrial septum to enable left atrial access during transseptal catheterization procedures. It provides torque control, is flexible with a tapered tip, and features an echogenic shaft and radiopaque tip for visualization during manipulation.
The subject device shares identical patient-contacting materials and fundamental design with its predicate but differs in hub color, dilator shaft dimensions, snap-fit hub geometry, and hub length. Non-patient contacting materials are similar, and labeling has been updated to reflect compatible access sheath models and device specifications.
ISO 11070:2014/Amd.1:2018, ISO 80369-7:2021, ISO 80369-20:2015, ISO 10993-1:2018, ISO 11135:2014/A1:2018, ISO 10993-7:2008/A1:2019, ISO 11607-1:2019, ANSI/AAMI ST72:2019
The subject and predicate devices have identical indications for use, intended use, and fundamental scientific technology operating on the same principle of mechanical force transfer for tissue dilation. Design and dimensional changes (hub color, shaft dimensions, snap-fit geometry) do not raise new safety or effectiveness questions, as verified through design verification, biocompatibility testing (adopted from predicate), sterilization validation, pyrogen testing, and benchtop validation showing the subject device performs equivalently in its intended use.
View the full FDA submission: accessdata.fda.gov