Niobe Magnetic Navigation System W/Navigant Workstation
FDA 510(k) K060967 · Stereotaxis, Inc.
510(k) numberK060967
Submission
- Device name
- Niobe Magnetic Navigation System W/Navigant Workstation
- Applicant
- Stereotaxis, Inc.
St. Louis, MO, US - Received
- April 7, 2006
- Decision date
- October 19, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NDQ – System, Catheter Or Guidewire, Steerable (Magnetic)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1290
- Specialty
- Cardiovascular
Other 510(k)s with product code NDQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K051373 | Cronus Guidewire, Model 001-001470-1NDQ · Traditional | Stereotaxis, Inc. | 12/09/2005SE |
More from Stereotaxis, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K262744 | GenesisX RMNDXX · Special | 08/27/2026SE |
| K253473 | SynchronyDQK · Traditional | 04/01/2026SE |
| K251792 | Stereotaxis GenesisX RMN with Navigant Workstation (NWS)DXX · Traditional | 11/06/2025SE |
| K250590 | MAGiC Sweep EP Mapping CatheterDRF · Traditional | 07/23/2025SE |
| K193147 | Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive SystemPJB · Traditional | 03/05/2020SE |
| K192775 | Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and CardiodriPJB · Special | 10/30/2019SE |
| K183027 | Steerable catheter control systemPJB · Traditional | 09/06/2019SE |
| K150312 | Vdrive system, Vdrive Duo, Vdrive with V-SonoDXX · Traditional | 06/17/2015SE |
| K141530 | Vdrive System/ Vdrive Duo/ Vdrive with V-CasDXX · Traditional | 12/18/2014SE |
| K140804 | Vdrive with V-Loop/ Vdrive DuoDXX · Traditional | 09/03/2014SE |
Questions and answers
When was Niobe Magnetic Navigation System W/Navigant Workstation cleared by the FDA?
Niobe Magnetic Navigation System W/Navigant Workstation (K060967) received a 510(k) decision of Substantially Equivalent on October 19, 2006, 195 days after the submission was received.
What is the product code of K060967?
The FDA product code is NDQ – System, Catheter Or Guidewire, Steerable (Magnetic), a Class II (moderate risk) device regulated under 21 CFR 870.1290.