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VersaCross™

by Baylis Medical Company Inc. 10 variants

Ref VSTK3021

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number06854470015PX Basic UDI-DI 00685447009511UDI-DIDate28 May 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  • Withdrawn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

Specification

EUDAMED

Device Name
VersaCross Steerable Access Solution
Model / Reference
VSTK3021
Primary DI / UDI-DI
00685447009511
Basic UDI-DI
06854470015PX
EMDN Code
C019015 Cardiac transseptal puncture kits
Device Class
Class III
Medical Purpose
The VersaCross Steerable Access Solution offers the individually packaged VersaCross RF Wire and VersaCross Steerable Sheath in one single shipping box for the convenience of the user. This kit 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.

Manufacturer details

EUDAMED SRN
CA-PR-000047675

Other devices from Baylis Medical Co., Inc.

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Properties

  • Sterile