Navigant Workstation with Niobe Magnetic Navigation System, Model NWS05
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K051760 FDA 510(k)
- FDA Product Code
- DXX 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 Navigant Workstation with Niobe Magnetic Navigation System is a system for catheter control that is steerable. It is designed to navigate a compatible magnetic device through tissue to designated target sites.
This device is supplied by Stereotaxis, Inc. and has received FDA 510(k) clearance with the number K051760. It is classified as a Class II device under product code DXX with special controls. The device is intended for use in cardiovascular procedures.
Frequently asked questions
What is the Navigant Workstation with Niobe Magnetic Navigation System used for?
This system is designed to guide compatible magnetic catheters through tissue during cardiovascular procedures. By using magnetic fields, it enables precise navigation to target sites, improving accuracy and control in interventions like ablation or structural heart repairs.
How is the Navigant Workstation with Niobe Magnetic Navigation System supplied?
The device is supplied as a complete workstation system by Stereotaxis, Inc. It includes the Niobe Magnetic Navigation System integrated with the Navigant Workstation, which requires compatible magnetic catheters for operation. The system is intended for use in clinical settings with appropriate infrastructure.
Is the Navigant Workstation with Niobe Magnetic Navigation System single-use or reusable?
The Navigant Workstation itself is a reusable medical device, as it is designed for repeated use in clinical environments. However, compatible catheters used with the system are typically single-use, adhering to standard sterile procedure protocols for patient safety.
What regulatory approval does the Navigant Workstation with Niobe Magnetic Navigation System hold?
The device has received FDA 510(k) clearance under the number K051760, classified as a Class II medical device under product code DXX. This clearance indicates it meets regulatory standards for cardiovascular catheter control systems and is intended for use in approved procedures.
What types of cardiovascular procedures can this system support?
The Navigant Workstation with Niobe Magnetic Navigation System is specifically designed for cardiovascular procedures where precise catheter navigation is critical. This includes complex interventions such as cardiac ablation, structural heart repairs, and other minimally invasive treatments requiring accurate device placement within the heart.
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: K051760 FDA 510(k) - NAVIGANT WORKSTATION WITH NIOBE MAGNETI..., Navigant Workstation With Niobe Magnetic Navigation System, Model Nws05 ..., NAVIGANT WORKSTATION WITH NIOBE MAGNETIC NAVIGATION… - 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 | K051760 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Stereotaxis, Inc.
Sources (1)
- FDA 510(k) K051760 24 fields · synced Oct 1, 2026