VersaCross Steerable Access Solution

FDA UDI

Class II (US FDA UDI)

by Baylis Médicale Cie Inc

Identity

Trade Name: VersaCross Steerable Access Solution FDA UDI
Generic Name: Cardiac transseptal access set FDA UDI
Device Name: 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)) FDA UDI
Model / Reference: VSTK0049 FDA UDI
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)) FDA UDI

Identifiers

Primary DI / UDI-DI: 00685447012283 FDA UDI
FDA Product Code: DYB FDA UDI
DXF FDA UDI
GMDN Term: Cardiac transseptal access set FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1340 FDA UDI
870.5175 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Cardiac transseptal access set

A comprehensive guide to the VersaCross Steerable Access Solution, a vital tool for medical professionals in cardiac transseptal access procedures.

Similar devices

Also classified as Cardiac transseptal access set.

HOTWIRE™ RF GUIDEWIRE — Atraverse Medical · Class II
Cook — COOK INCORPORATED · Class II
HeartSpan® — Merit Medical · Class II
HeartSpan® — Merit Medical · Class II
Cook — COOK INCORPORATED · Class II
PathBuilder Transseptal Guiding Introducer — Shanghai Microport Ep Medtech Co., Ltd. · Class II
HeartSpan® — Merit Medical Systems, Inc. · Class II
TSX™ — Merit Medical · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Baylis Médicale Cie Inc

Sources (1)

FDA UDI e6852e98-72c9-4a97-b083-dc9ee2d532c6 34 fields · synced Jul 17, 2026