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VersaCross™

by Boston Scientific Corporation 11 variants

Ref M004VXSK30110

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number01915060000000000000669P2 Basic UDI-DI 00191506071929UDI-DIDate30 Jul 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

EU market availability

Not listed: EUDAMED names no country where this device is made available.

Declared by the manufacturer in EUDAMED for this device version; may not cover every market.

Last checked 30 Oct 2026.

Specification

EUDAMED

Device Name
VersaCross Access Solution
Model / Reference
M004VXSK30110
Primary DI / UDI-DI
00191506071929
Basic UDI-DI
01915060000000000000669P2
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

  • Sterile