VersaCross™

Device Name

VersaCross Access Solution

Model / Reference

VXSK3021

Primary DI / UDI-DI

00685447009030

Basic UDI-DI

06854470014PV

EMDN Code

C019015 Cardiac transseptal puncture kits

Device Class

Class III

Medical Purpose

The VersaCross Access Solution offers the individually packaged VersaCross RF Wire and VersaCross Transseptal Sheath in one single shipping box for the convenience of the user. This procedure pack provides the customer with all the devices required for transseptal access during the cardiovascular therapy procedures requiring introduction of various types of cardiovascular catheters and guidewires to all heart chambers.

EUDAMED SRN

CA-PR-000047675

• VersaCross Connect™

  Class III

  CE/MDR

• VersaCross™

  Class III

  CE/MDR

• Nrg™

  Class III

  CE/MDR

• Polaris RF Ablation System

  Class II

  FDA 510(k) K181864 Active Cleared 2 Jan 2019

• Epicardial Access System

  Class II

  FDA 510(k) K213582 Active Cleared 30 Jun 2022

• PORTAGE System

  Class II

  FDA 510(k) K161878 Active Cleared 26 Sep 2016

See all devices from Baylis Medical Company Inc. →