VersaCross Connect™

Device Name

VersaCross Connect Access Solution

Model / Reference

VXAK3005

Primary DI / UDI-DI

00685447016588

Basic UDI-DI

06854470026Q4

EMDN Code

C019015 Cardiac transseptal puncture kits

Device Class

Class III

Medical Purpose

The VersaCross Connect Access Solution Procedure Packs provide the VersaCross RF Wire and compatible connector cable with compatible VersaCross Connect Transseptal Dilator in a single sterile barrier. These solutions provide the customer with all the devices required for transseptal access during the cardiovascular therapy procedures requiring the introduction of various types of cardiovascular catheters and guidewires to all heart chambers within a single sterile barrier.

EUDAMED SRN

CA-PR-000047675

• VersaCross™

  Class III

  CE/MDR

• Nrg™

  Class III

  CE/MDR

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  FDA 510(k) K161878 Active Cleared 26 Sep 2016

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  Class II

  FDA 510(k) K132374 Active Cleared 30 Aug 2013

See all devices from Baylis Medical Company Inc. →