Catheter Remote Control System
The Catheter Remote Control System is an external device that interacts with the manual handle of a steerable cardiac ablation catheter to remotely control the advancement, retraction, rotation, and deflection of the catheter during treatment of cardiac arrhythmias in the right side of the heart, while allowing reversion to manual control without catheter withdrawal. It is an FDA Class 2 device regulated under 21 CFR 870.5700, requiring 510(k) premarket notification, within the Cardiovascular (CV) medical specialty. The product code is PJB. This device is not implantable and is not life-sustaining.
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Basic Information
- Product Code
- PJB
- Device Class
- FDA class 2
- Regulation Number
- 870.5700
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
Definition
A steerable cardiac ablation catheter remote control system is a device that is external to the body and interacts with the manual handle of a steerable cardiac ablation catheter to remotely control the advancement, retraction, rotation, and deflection of a steerable ablation catheter used for the treatment of cardiac arrhythmias in the right side of the heart. The device allows reversion to manual control of the steerable cardiac ablation catheter without withdrawal of the catheter and interruption of the procedure.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K193147 | Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System | Mar 05, 2020 | Substantially Equivalent | Stereotaxis, Inc. |
| K192775 | Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri | Oct 30, 2019 | Substantially Equivalent | Stereotaxis, Inc. |
| K183027 | Steerable catheter control system | Sep 06, 2019 | Substantially Equivalent | Stereotaxis, Inc. |
| DEN140009 | AMIGO REMOTE CATHETER SYSTEM | Dec 18, 2014 | Unknown | Catheter Robotics, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.