Catheter Robotics, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Catheter Robotics, Inc. makes
Catheter Robotics, Inc. manufactures the AMIGO Remote Catheter System, a robotic-assisted catheter platform designed for precise interventional procedures. The system includes the main robotic unit and associated accessories to support remote catheter navigation and manipulation. It is intended for use in medical imaging-guided interventions, such as coronary angiography and percutaneous coronary interventions.
The AMIGO Remote Catheter System is classified as a Class II medical device under FDA regulations and is authorised via the 510(k) pathway. The company is based in the United States. The system’s regulatory status is recorded in the FDA’s 510(k) database.
Catalogue
Amigo Remote Catheter System Ref DEN140009
Regimes: De Novo Registry: De NovoAmigo Remote Catheter System & Accessories Ref K122488
Regimes: 510(k) Registry: 510(k)Amigo Remote Catheter System (Rcs) & Accessories Ref K113628
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Catheter Robotics, Inc. have in the registry?
The registry currently lists 3 devices for Catheter Robotics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Catheter Robotics, Inc.'s devices?
Among its 3 most recently registered devices, Catheter Robotics, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Catheter Robotics, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Catheter Robotics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Catheter Robotics, Inc. in the registry?
The most recently registered devices listed for Catheter Robotics, Inc. include AMIGO REMOTE CATHETER SYSTEM, AMIGO REMOTE CATHETER SYSTEM & ACCESSORIES and AMIGO REMOTE CATHETER SYSTEM (RCS) & ACCESSORIES.