# K021481: Bresagen Catheter, Model CS-3000

- Pathway: 510(k) (Traditional)
- Applicant: Bresagen, Inc.
- Decided: Aug 6, 2002 after 90 days
- Product code: HCA (Catheter, Ventricular)
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
For injection of material into, or removal of material from, the brain during intracranial procedures. This device is not intended for implant. This device is ET0 sterilized and intended for one time use only.

Source page: https://510kreport.com/device/K021481
Methodology: https://510kreport.com/methodology