V-CAS Catheter Advancement System

FDA UDI

Class II (US FDA UDI)

by Stereotaxis, Inc.

Identity

Trade Name: V-CAS Catheter Advancement System FDA UDI
Generic Name: Cardiac mapping system workstation FDA UDI
Device Name: The Vdrive with V-CAS Disposable is indicated for remotely controlling the advancement, retraction, and rotation of compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System FDA UDI
Model / Reference: 1 FDA UDI
Description: The Vdrive with V-CAS Disposable is indicated for remotely controlling the advancement, retraction, and rotation of compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System FDA UDI

Identifiers

Catalog Number: 001-002422-1 FDA UDI
Primary DI / UDI-DI: M58800100242210 FDA UDI
FDA Product Code: DXX FDA UDI
DQX FDA UDI
GMDN Term: Cardiac mapping system workstation FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1290 FDA UDI
870.1330 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

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 mapping system workstation

V-CAS Catheter Advancement System by Stereotaxis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Stereotaxis, Inc.

Sources (1)

FDA UDI e432a817-5b96-49e8-8667-a89a31950270 36 fields · synced Jun 1, 2026