# K160223: VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation, VentriClear II Ventricular Drainage Catheter

- Pathway: 510(k) (Special)
- Applicant: Cook Incorporated
- Decided: Apr 8, 2016 after 70 days
- Product code: NHC (Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents))
- Device class: 2
- Regulation: 21 CFR 882.4100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K011812 (2001). 2 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011812: Spectrum Ventricular Catheter, Cook, Inc. (2001) Summary page 4.
- K071640: Ventriclear II, Spectrum Ventricular Drainage Catheter, Model N-VVDC-02-Abrm, Cook, Inc. (2007) Summary page 4.

## Most influential descendants
- K171880: IRRAflow CNS System (2018), 4 descendants of its own
- K192289: IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit (2019), 3 descendants of its own
- K200807: IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit (2020), 2 descendants of its own
- K222471: IRRAflow Active Fluid Exchange System (AFES) (2022), 1 descendant of its own
- K231664: IRRAflow Active Fluid Exchange System (AFES) (2023), 0 descendants of its own

## Indications for use
The VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation and the VentriClear II Ventricular Drainage Catheter have been designed for obtaining access to a ventricular cavity of the brain for short-term use to externally drain fluid for the purpose of relieving elevated intracranial pressure or fluid volume.

Source page: https://510kreport.com/device/K160223
Methodology: https://510kreport.com/methodology