510(k) DEN140009
- Device
- AMIGO REMOTE CATHETER SYSTEM
- Applicant
- Catheter Robotics, Inc.
- 510(k) number
- DEN140009
- Product code
- PJB
- Decision
- Unknown (DENG)
- Decision date
- 2014-12-18
- Date received
- 2014-02-18
- Regulation
- 870.5700
- Classification name
- Catheter Remote Control System
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- JENNIFER ENGLUND
- Address
- 500 International Dr., Suite 255 Mt. Olive NJ US 07828 07828
FDA Registration Numbers#
- 3003084417
Source Documents#
510(k) summary PDF not indicated by FDA
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 |
| K192775 | Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri | Stereotaxis, Inc. | 2019-10-30 |
| K183027 | Steerable catheter control system | Stereotaxis, Inc. | 2019-09-06 |