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VersaCross Access Solution VXSK0012

by Baylis Médicale Cie Inc 3 variants

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00685447017158 UDI-DI Date22 Jul 2022ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
VersaCross Access Solution
Generic Name
Cardiac transseptal access set
Model / Reference
VXSK0012
Description
1 x VersaCross Transseptal Sheath (including 1 x J-tip Guidewire); 1 x VersaCross RF Wire (including 1 x Connector Cable (Single Use))
Primary DI / UDI-DI
00685447017158
FDA Product Code
DXF, DYB
GMDN Term
Cardiac transseptal access set
Device Class
Class II
Regulation Number
870.5175, 870.1340
GUDID distribution status
Not in Commercial Distribution

Other devices from Baylis Médicale Cie Inc

See all devices from Baylis Médicale Cie Inc →

Properties

  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No