510(k) K192775
- Device
- Niobe® Magnetic Navigation System (MNS) With Navigant Workstation (NWS) And Cardiodri
- Applicant
- Stereotaxis, Inc.
- 510(k) number
- K192775
- Product code
- PJB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-10-30
- Date received
- 2019-09-30
- Regulation
- 870.5700
- Classification name
- Catheter Remote Control System
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Kenneth H. Lock
- Address
- 4320 Forest Park Ave., Suite 100 St. Louis MO US 63108 63108
FDA Registration Numbers#
- 3003084417
Source Documents#
Other 510(k) Records For Product Code PJB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K193147 | Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System | Stereotaxis, Inc. | 2020-03-05 |
| K183027 | Steerable catheter control system | Stereotaxis, Inc. | 2019-09-06 |
| DEN140009 | AMIGO REMOTE CATHETER SYSTEM | Catheter Robotics, Inc. | 2014-12-18 |
Legacy Summary#
summary
FDA Review#
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