Identity
- Trade Name
- Navigant FDA UDI
- Generic Name
- Cardiac mapping system workstation FDA UDI
- Device Name
- The Navigant Navigation Workstation (NWS) is a component of the Magnetic Navigation System (MNS). The MNS with NWS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart and coronary vasculature by orienting the device tip in a desired direction. The Navigant feature provides an enhanced navigation interface for the physician to control the MNS. FDA UDI
- Model / Reference
- 5.0.7 FDA UDI
- Description
- The Navigant Navigation Workstation (NWS) is a component of the Magnetic Navigation System (MNS). The MNS with NWS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart and coronary vasculature by orienting the device tip in a desired direction. The Navigant feature provides an enhanced navigation interface for the physician to control the MNS. FDA UDI
Identifiers
- Catalog Number
- 020-004500-36 FDA UDI
- Primary DI / UDI-DI
- M588020004500360 FDA UDI
- 510(k) Number
- K193147 FDA UDI
- FDA Product Code
- NDQ FDA UDI
- GMDN Term
- Cardiac mapping system workstation FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1290 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cardiac mapping system workstation
Navigant by Stereotaxis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K193147 also covers:
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 929dc7dc-aea9-4733-a977-5daa9d1b59b7 36 fields · synced May 30, 2026