# HCA: Catheter, Ventricular

- Device class: 2; regulation: 21 CFR 882.4100; FDA's rule: 510(k) required
- FDA decisions: 10
- Recalls: 5 (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)
- 1984: 1
- 1998: 1
- 1999: 1
- 2001: 1
- 2002: 3
- 2003: 1
- 2013: 1
- 2017: 1

## Most-cited predicates
- K003322: Codman Bactiseal Catheters (2001), cited by 4
- K020728: Miethke Shunt System (2002), cited by 2
- K031123: Codman Bactiseal Barium Striped Catheters (2003), cited by 2
- K013005: Act 11 MP Ventricular Catheter (2002), cited by 1
- K123605: Smartflow Catheter (2013), cited by 1

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