VersaCross™
by Baylis Medical Company Inc. 10 variants
Ref VXSK3031
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number06854470014PV 00685447009092 | Date2 Apr 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- VersaCross Access Solution
- Model / Reference
- VXSK3031
- Primary DI / UDI-DI
- 00685447009092
- Basic UDI-DI
- 06854470014PV
- EMDN Code
- C019015 Cardiac transseptal puncture kits
- Device Class
- Class III
- Medical Purpose
- The VersaCross Access Solution offers the individually packaged VersaCross RF Wire and VersaCross Transseptal Sheath in one single shipping box for the convenience of the user. This procedure pack 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