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VersaCross Connect Transseptal Dilator

FDA 510(k)

Class II (US FDA 510(k))

510(k) K233647

by Baylis Medical Company Inc.

Identifiers

510(k) Number
K233647 FDA 510(k)
FDA Product Code
DRE FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1310 FDA 510(k)
Regulation Number
870.1310 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The VersaCross Connect Transseptal Dilator is a dilator, vessel, for percutaneous catheterization designed for transseptal access procedures. It facilitates the creation of an atrial septal defect to enable delivery of left heart therapy devices, supporting interventions such as left atrial appendage occlusion (LAAO).

This device is supplied as a single-use, non-sterile instrument, available in two wire lengths (180 cm and 230 cm) paired with a 12 French dilator (85 cm length, 0.035" D1 curve). It is intended for use in electrophysiology laboratories and has received FDA 510(k) clearance under the classification of Class II medical devices. No MRI safety information is specified.

Frequently asked questions

What is the primary use of the VersaCross Connect Transseptal Dilator in clinical practice?

The VersaCross Connect Transseptal Dilator is specifically designed for transseptal access procedures, creating an atrial septal defect to enable the delivery of left heart therapy devices. This is particularly useful in electrophysiology labs for interventions like left atrial appendage occlusion (LAAO), where accessing the left atrium is necessary.

Is the VersaCross Connect Transseptal Dilator intended for single-use or reusable applications?

The device is explicitly supplied as a single-use instrument, meaning it is not meant for reuse after a single procedure. This design choice aligns with best practices for patient safety and sterility.

What are the available sizes or configurations for the VersaCross Connect Transseptal Dilator?

The device comes in two wire length options—180 cm and 230 cm—each paired with a 12 French dilator that measures 85 cm in length and features a 0.035” D1 curve. These configurations accommodate different procedural needs while maintaining compatibility with standard catheterization setups.

How should the VersaCross Connect Transseptal Dilator be stored, and is it sterile?

The device is supplied in a non-sterile state, meaning it requires terminal sterilization or preparation by the facility prior to use. Storage should follow manufacturer guidelines to preserve its integrity, though specific conditions (e.g., temperature, humidity) are not detailed in the data. Always check the packaging for any additional handling instructions.

What regulatory pathway was followed for FDA clearance of this device?

The VersaCross Connect Transseptal Dilator received FDA 510(k) clearance under the classification of Class II medical devices, with a substantially equivalent determination by the Cardiovascular (CV) Advisory Committee. The clearance was granted as a special type, indicating a unique or innovative approach compared to predicate devices.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: VersaCross™ Access Solution - Boston Scientific, Baylis VXAK0003 VersaCross Connect™ LAAC Access Solution - MedicalEcart, Baylis VXAK0007 VersaCross Connect™ LAAC Access Solution, VersaCross Connect™ Transseptal Dilator 510(k) K251325 - fda.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Baylis Medical Company Inc.
FDA Applicant
Baylis Medical Company, Inc.

Sources (1)

  • FDA 510(k) K233647 24 fields · synced Oct 6, 2026