VersaCross™

EUDAMED

Class III (EU MDR)

Ref VXSK3001Ref VSTK3003Ref VSTK3015Ref VSTK3022Ref VSTK3019Ref VSTK3018

Identity

Trade Name: VersaCross™ EUDAMED
Device Name: VersaCross Access Solution EUDAMED
VersaCross Steerable Access Solution EUDAMED
Model / Reference: VXSK3001 EUDAMED
VSTK3003 EUDAMED
VSTK3015 EUDAMED
VSTK3022 EUDAMED
VSTK3019 EUDAMED
VSTK3018 EUDAMED

Primary DI / UDI-DI: 00685447008910 EUDAMED
00685447009337 EUDAMED
00685447009450 EUDAMED
00685447009528 EUDAMED
00685447009535 EUDAMED
00685447009443 EUDAMED
Basic UDI-DI: 06854470014PV EUDAMED
06854470015PX EUDAMED
EMDN Code: C019015 CARDIAC TRANSSEPTAL PUNCTURE KITS EUDAMED

Device Class: Class III EUDAMED
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. EUDAMED
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. EUDAMED

Sterile

Yes

EUDAMED

VersaCross™ by Baylis Medical Company Inc. — Class III — MDR — listed in EUDAMED — regulatory data on deviCERTS

European Union Active

CE/MDR

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	06854470014PV	Class III	Active

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