Niobe Magnetic Navigation System W/Navigant Workstation
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K060967 FDA 510(k)
- FDA Product Code
- NDQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1290 FDA 510(k)
- Regulation Number
- 870.1290 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Niobe Magnetic Navigation System W/Navigant Workstation is a steerable catheter control system that is connected to the proximal end of a steerable guide wire to control the motion of the steerable catheter. It is an interventional workstation for intravascular navigation of magnetically-adapted devices, using computer-controlled permanent magnets to orient device tips and remotely advance or retract compatible EP mapping and ablation catheters.
The system is supplied as a reusable device intended for use in cardiovascular interventional settings. It operates under FDA 510(k) clearance (K060967) and is classified as a Class II device under regulation number 870.1290, with product code NDQ. No information regarding sterility, single-use status, MRI safety, specific sizes, or storage conditions is provided in the data.
Frequently asked questions
What is the Niobe Magnetic Navigation System W/Navigant Workstation used for?
It is used to control the motion of steerable catheters by connecting to the proximal end of a steerable guide wire, enabling intravascular navigation of magnetically-adapted EP mapping and ablation catheters through computer-controlled permanent magnets that orient device tips and allow remote advancement or retraction.
Is the Niobe Magnetic Navigation System W/Navigant Workstation reusable or single-use?
The system is supplied as a reusable device, meaning it is designed for multiple uses after appropriate cleaning and reprocessing between procedures, as indicated in the device description.
What type of regulatory clearance does the Niobe Magnetic Navigation System W/Navigant Workstation have?
It operates under FDA 510(k) clearance with the specific clearance number K060967, which was granted as a traditional 510(k) submission found substantially equivalent to a predicate device.
What is the device classification and product code for the Niobe Magnetic Navigation System W/Navigant Workstation?
It is classified as a Class II medical device under regulation number 870.1290 and assigned product code NDQ, which corresponds to steerable magnetic catheter or guidewire systems in the cardiovascular specialty.
What clinical setting is the Niobe Magnetic Navigation System W/Navigant Workstation intended for?
It is intended for use in cardiovascular interventional settings, specifically for navigating magnetically-adapted devices during intravascular procedures such as electrophysiology mapping and ablation.
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: Niobe Magnetic Navigation System W/Navigant Workstation (K060967) — Fda ..., Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS ..., NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT… - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K060967 | Class II | Active |
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Manufacturer
- Manufacturer
- Stereotaxis, Inc.
Sources (1)
- FDA 510(k) K060967 24 fields · synced Sep 26, 2026