Stereotaxis Catheter Advancer System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K021802 FDA 510(k)
- FDA Product Code
- DQY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1250 FDA 510(k)
- Regulation Number
- 870.1250 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Stereotaxis Catheter Advancer System is an electromechanical tool that automates the advancement and retraction of electrophysiology catheters used in cardiac electrophysiology procedures. It provides precise, stable, and flexible catheter positioning to support minimally invasive cardiac ablation and arrhythmia mapping.
The system is supplied as a sterile, single‑use advancer that includes an electrically powered controller, motor, and user interface. It was cleared through a traditional FDA 510(k) submission (K021802) and is classified under product code DQY for cardiovascular devices. The device is intended for use with Stereotaxis robotic platforms in cardiac electrophysiology settings.
Frequently asked questions
What is the Stereotaxis Catheter Advancer System used for?
The Stereotaxis Catheter Advancer System is an electromechanical tool that automates the advancement and retraction of electrophysiology catheters during cardiac electrophysiology procedures, providing precise, stable, and flexible catheter positioning to support minimally invasive cardiac ablation and arrhythmia mapping.
How is the Stereotaxis Catheter Advancer System supplied and is it reusable?
The system is supplied as a sterile, single-use advancer that includes an electrically powered controller, motor, and user interface, meaning it is intended for one-time use only and not designed for reuse or reprocessing.
What regulatory pathway was used for the Stereotaxis Catheter Advancer System and what is its classification?
The device was cleared through a traditional FDA 510(k) submission (K021802) and is classified under product code DQY for cardiovascular devices, indicating it was found substantially equivalent to a predicate device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Stereotaxis Products, Stereotaxis (company) - Wikipedia, STEREOTAXIS CATHETER ADVANCER SYSTEM - Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K021802 | Class II | Active |
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Manufacturer
- Manufacturer
- Stereotaxis, Inc.
Sources (1)
- FDA 510(k) K021802 24 fields · synced Sep 24, 2026