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VersaCross™

by Boston Scientific Corporation United States EUDAMED

Ref M004VSTK30220

EMDN C019015

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number01915060000000000000667NW Basic UDI-DIDate30 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
VersaCross Steerable Access Solution
Model / Reference
M004VSTK30220
Primary DI / UDI-DI
00191506071776
Basic UDI-DI
01915060000000000000667NW
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

Other devices from Boston Scientific

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Properties & raw data

Show properties, registry sources and raw records
  • Sterile

Sources (1)

  • EUDAMED 00191506071776|01915060000000000000667NW 61 fields · synced 24 Oct 2026