Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System
FDA 510(k) clearance K193147 · decided 2020-03-05
Clearance details
- K-number
- K193147
- Device name
- Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System
- Applicant
- Stereotaxis, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-11-13
- Decision date
- 2020-03-05
- Days to decision
- 113 days
- Clearance type
- Traditional
- Product code
- PJB
- Device class
- 2
- Regulation number
- 870.5700
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- St. Louis, MO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri (K192775) | Stereotaxis, Inc. | 2019-10-30 |
| Steerable catheter control system (K183027) | Stereotaxis, Inc. | 2019-09-06 |
| AMIGO REMOTE CATHETER SYSTEM (DEN140009) | Catheter Robotics, Inc. | 2014-12-18 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| HELIOS II ABLATION CATHETER (P050029) | Stereotaxis, Inc. | 2008-10-10 |