VersaCross Connect™
by Baylis Medical Company Inc. 8 variants
Ref VXAK3031
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 | Number06854470026Q4 00685447019015 | 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- Withdrawn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 Connect Access Solution
- Model / Reference
- VXAK3031
- Primary DI / UDI-DI
- 00685447019015
- Basic UDI-DI
- 06854470026Q4
- EMDN Code
- C019015 Cardiac transseptal puncture kits
- Device Class
- Class III
- Medical Purpose
- The VersaCross Connect Access Solution Procedure Packs provide the VersaCross RF Wire and compatible connector cable with compatible VersaCross Connect Transseptal Dilator 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
- CA-PR-000047675