# MTD: Catheter, Intracardiac Mapping, High-Density Array

- Device class: 2; regulation: 21 CFR 870.1220; FDA's rule: 510(k) required
- FDA decisions: 34
- 510(k) review time 2021–2025: median 200 days (middle half 63–323)
- Recalls: 3 (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: 2
- 2016: 1
- 2017: 2
- 2018: 1
- 2020: 4
- 2021: 1
- 2022: 2
- 2023: 3
- 2024: 2
- 2026: 2

## Most-cited predicates
- K130827: Firmap Catheter (2013), cited by 5
- K123837: Pentaray Nav Eco High-Density Mapping Catheter (2013), cited by 4
- K172393: Advisor HD Grid Mapping Catheter, Sensor Enabled (2018), cited by 4
- K983171: Constellation Multiple Electrode Pacing and Recording System (1999), cited by 3
- K231312: PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto ID (2023), cited by 3
- K021232: Constellation Catheters, Model 8031M (2002), cited by 3
- K992777: Constellation Catheters, Model 8039 (1999), cited by 2
- K201750: Pentaray Nav eco High-Density Mapping Catheter (2020), cited by 2
- K120425: Pentaray Nav High-Density Mapping Catheter (2012), cited by 2
- K003782: Constellation Catheter, Model 8031 (2001), cited by 2

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