Panels › Cardiovascular › Product code PJB · Class 2
Catheter Remote Control System
Regulation 870.5700
0510(k)s in 12 months (4 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in PJB
| Company | 510(k)s | Recalls |
|---|---|---|
| Stereotaxis, Inc. | 3 | 1 |
| Catheter Robotics, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 5, 2020 | K193147 | Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System Stereotaxis, Inc. | PJB |
| Oct 30, 2019 | K192775 | Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri Stereotaxis, Inc. | PJB |
| Sep 6, 2019 | K183027 | Steerable catheter control system Stereotaxis, Inc. | PJB |
| Dec 18, 2014 | DEN140009 | AMIGO REMOTE CATHETER SYSTEM Catheter Robotics, Inc. | PJB |
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