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: VSTK0035 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: 00685447012214 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

VersaCross Steerable Access Solution by Baylis Médicale Cie Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac transseptal access set.

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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

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Manufacturer

Manufacturer: Baylis Médicale Cie Inc

Sources (1)

FDA UDI fd58bdf5-9515-43b9-bffe-7b8e9c0f9763 34 fields · synced Jun 8, 2026