# NHC: Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents)

- Device class: 2; regulation: 21 CFR 882.4100; FDA's rule: 510(k) required
- FDA decisions: 3
- 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)
- 2001: 1
- 2007: 1
- 2016: 1

## Most-cited predicates
- K011812: Spectrum Ventricular Catheter (2001), cited by 3
- K071640: Ventriclear II, Spectrum Ventricular Drainage Catheter, Model N-VVDC-02-Abrm (2007), cited by 1
- K160223: VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation, VentriClear II Ventricular Drainage Catheter (2016), cited by 1

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