Identity
- Trade Name
- VersaCross Connect™ EUDAMED
- Device Name
- VersaCross Connect Access Solution EUDAMED
- Model / Reference
- M004VXAK30410 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00191506071851 EUDAMED
- Basic UDI-DI
- 01915060000000000000668NY EUDAMED
- EMDN Code
- C019015 CARDIAC TRANSSEPTAL PUNCTURE KITS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- 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. EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
VersaCross Connect™ by Boston Scientific Corporation — Class III — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 01915060000000000000668NY | Class III | Active |
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Manufacturer
- Manufacturer
- Boston Scientific Corporation
- EUDAMED SRN
- US-PR-000008885
Sources (1)
- EUDAMED c396b492-02d2-4c5e-9462-eb8e4c5515f7 61 fields · synced Jun 18, 2026