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VersaCross Connect™

by Boston Scientific Corporation United States EUDAMED

Ref M004VXAK30450

EMDN C019015

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number01915060000000000000668NY Basic UDI-DIDate29 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
VersaCross Connect Access Solution
Model / Reference
M004VXAK30450
Primary DI / UDI-DI
00191506071875
Basic UDI-DI
01915060000000000000668NY
EMDN Code
C019015 Cardiac transseptal puncture kits
Device Class
Class III
Medical Purpose
The RF Wire Transseptal Access Solution Procedure Packs provide the VersaCross RF Wire and compatible connector cable with compatible sheath/dilator devices 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.

Manufacturer details

EUDAMED SRN
US-PR-000008885

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Properties & raw data

Show properties, registry sources and raw records
  • Sterile

Sources (1)

  • EUDAMED 00191506071875|01915060000000000000668NY 61 fields · synced 25 Oct 2026