FDA Product Code
FDA Product Code PJB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.5700
510(k) Clearances — 4 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K193147 | Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System | Stereotaxis, Inc. | 2020-03-05 | Traditional | PDF ↗ |
| K192775 | Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri | Stereotaxis, Inc. | 2019-10-30 | Special | PDF ↗ |
| K183027 | Steerable catheter control system | Stereotaxis, Inc. | 2019-09-06 | Traditional | PDF ↗ |
| DEN140009 | AMIGO REMOTE CATHETER SYSTEM | Catheter Robotics, Inc. | 2014-12-18 | Direct | — |
Product code PJB · Class II · Cardiovascular. Data: openFDA.