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VersaCross Connect LAAC Access Solution VXAK0013

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 Number00685447010562 UDI-DI Date19 May 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  • Withdrawn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 Connect LAAC Access Solution
Generic Name
Cardiac transseptal access set
Model / Ref / Catalog
VXAK0013
Primary DI / UDI-DI
00685447010562
FDA Product Code
DRE, DXF
GMDN Term
Cardiac transseptal access set
Device Class
Class II
Regulation Number
870.1310, 870.5175
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