# K170599: SureFlo EVD Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Arkis Biosciences, Inc.
- Decided: Aug 31, 2017 after 183 days
- Product code: JXG (Shunt, Central Nervous System And Components)
- Device class: 2
- Regulation: 21 CFR 882.5550
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K864676 (1986). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972994: External CSF Drainage Management Systems, Integra Neurocare, LLC (1997) Summary page 4.
- K081942: Neurocath AG, Vygon Neuro (2008) Summary page 4.

## Recalls of this device
- Apr 10, 2026 · Class II · Z-2173-2026: Out-of-specification endotoxin result that did not meet the acceptance criteria.

## Indications for use
The SureFlo EVD Catheter is indicated for temporary insertion into a ventricular cavity of the brain for external drainage of cerebrospinal fluid (CSF) in those patients with elevated intracranial pressure (ICP), intraventricular hemorrhage, or hydrocephalic shunt infections.

Source page: https://510kreport.com/device/K170599
Methodology: https://510kreport.com/methodology