# Catheter Robotics, Inc.

- Location (FDA's records): Mount Olive, NJ
- FDA decisions: 3 (2012–2014): 2 510(k) clearances and 1 De Novo grant
- Product codes: DXX (2), PJB (1)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 2 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Hansen Medical, Inc.: 1 (https://510kreport.com/company/hansen-medical)
- Stereotaxis, Inc.: 1 (https://510kreport.com/company/stereotaxis)

## Firms that cite its devices most
- Stereotaxis, Inc.: 1 (https://510kreport.com/company/stereotaxis)

## Its most-cited devices
- DEN140009: Amigo Remote Catheter System (2014), cited by 1
- K113628: Amigo Remote Catheter System (RCS) & Accessories (2012), cited by 1

## Recent decisions
- DEN140009: Amigo Remote Catheter System (Dec 18, 2014)
- K122488: Amigo Remote Catheter System & Accessories (Nov 20, 2012)
- K113628: Amigo Remote Catheter System (RCS) & Accessories (Jun 12, 2012)

Source page: https://510kreport.com/company/catheter-robotics