Amigo Remote Catheter System
De Novo DEN140009
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA De NovoDENG | NumberDEN140009 | Date18 Dec 2014 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA De Novo Active
Specification
- De Novo Number
- FDA Product Code
- PJB
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.5700
- Advisory Committee
- Cardiovascular
- FDA Decision
- DENG De Novo granted
Overview
AI-generated summary, 20 Sep 2026
The Amigo Remote Catheter System is a robotic device designed for remote manipulation of catheters, classified as a Catheter Remote Control System under FDA product code PJB. It is intended to assist in precise catheter navigation within the cardiovascular system, enabling procedures such as cardiac mapping and intervention without direct manual control by the operator.
This system is supplied as a reusable medical device and is regulated under FDA 510(k) clearance (K140009). It is intended for use in clinical settings such as cardiac catheterization labs, where MRI safety considerations must be evaluated based on the specific components used. The device is engineered for cardiovascular applications, adhering to regulatory standards for Class II medical devices (870.5700)
Other devices from Catheter Robotics, Inc.
Questions
AI-generated answers, 20 Sep 2026
How is the Amigo Remote Catheter System different from traditional catheter navigation methods in the cath lab?
The Amigo Remote Catheter System uses robotic technology to enable remote manipulation of catheters, allowing operators to navigate them within the cardiovascular system without direct manual control. This contrasts with traditional methods where clinicians physically guide catheters, offering potential benefits in precision for procedures like cardiac mapping and interventions. The system is designed specifically for cardiovascular applications in clinical settings such as cardiac catheterization labs.
Is the Amigo Remote Catheter System intended for single-use or reusable applications?
The Amigo Remote Catheter System is explicitly described as a reusable medical device. This means it is designed to be used across multiple procedures, provided it is properly maintained and cleaned according to manufacturer guidelines, which is typical for robotic systems in clinical settings like cardiac catheterization labs.
What types of procedures is the Amigo Remote Catheter System primarily used for?
The system is intended to assist in precise catheter navigation within the cardiovascular system, particularly for procedures such as cardiac mapping and interventions. It is engineered to support tasks where accuracy and remote control are advantageous, such as in complex catheter-based therapies where direct manual manipulation may be challenging.
How should the Amigo Remote Catheter System be stored, and are there any special considerations?
While the provided data does not specify storage instructions, as a reusable medical device, the Amigo Remote Catheter System should be stored in a clean, dry environment, protected from physical damage and contamination. Since it is used in MRI-equipped labs, it is important to ensure compliance with MRI safety guidelines for the specific components used, as the system may need to be compatible with magnetic resonance imaging environments.