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VersaCross Steerable Access Solution VSTK0018

by Baylis Médicale Cie Inc 3 variants

VersaCross Steerable Access Solution VSTK0018 is a cardiac transseptal access set (FDA Class II) made by Baylis Médicale Cie Inc, listed in FDA GUDID since 4 Aug 2022 (UDI-DI 00685447012092), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

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

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00685447012092 UDI-DI Date4 Aug 2022ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
VersaCross Steerable Access Solution
Generic name
Cardiac transseptal access set
Model / Ref / Catalog
VSTK0018
Description
1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross RF Wire (including 1 x Connector Cable (Single Use))
Primary DI / UDI-DI
00685447012092
FDA product code
DXF, DYB
GMDN term
Cardiac transseptal access set
Device class
Class II
Regulation number
870.5175, 870.1340
GUDID distribution status
In Commercial Distribution

Related devices

Category: Cardiac transseptal access set

Similar devices in this category

Other devices filed under Cardiac transseptal access set.

Other devices from Baylis Médicale Cie Inc

See all devices from Baylis Médicale Cie Inc →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)