# K030081: CSF400 and CSF600

- Pathway: 510(k) (Traditional)
- Applicant: Inmed Ltda.
- Decided: Oct 6, 2003 after 270 days
- Product code: JXG (Shunt, Central Nervous System And Components)
- Device class: 2
- Regulation: 21 CFR 882.5550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K820247 (1982). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K820247: External Ventricular Drainage Sys., American Heyer Schulte (1982) Summary page 1.

## Indications for use
This device is a disposable system designed for the drainage of cerebrospinal fluid from the brain ventricles to a calibrated collection bag, graduated to provide an approximate volume measurement of the fluid collected, and is indicated for use to relieve elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus).

Source page: https://510kreport.com/device/K030081
Methodology: https://510kreport.com/methodology