# PJB: Catheter Remote Control System

- Device class: 2; regulation: 21 CFR 870.5700; FDA's rule: 510(k) required
- FDA decisions: 4
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2014: 1
- 2019: 2
- 2020: 1

## Most-cited predicates
- K192775: Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri (2019), cited by 1
- K183027: Steerable catheter control system (2019), cited by 1
- DEN140009: Amigo Remote Catheter System (2014), cited by 1

Source page: https://510kreport.com/product-code/PJB
Data by year (CSV): https://510kreport.com/product-code/PJB.csv