# K110560: Medtronic Ares Antibiotic-Impregnated Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Neurosurgery
- Decided: Nov 18, 2011 after 263 days
- Product code: JXG (Shunt, Central Nervous System And Components)
- Device class: 2
- Regulation: 21 CFR 882.5550
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K003322 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003322: Codman Bactiseal Catheters, Codman & Shurtleff, Inc. (2001) Summary page 1.

## Most influential descendants
- K242003: XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set (2024), 0 descendants of its own

## Recalls of this device
- Dec 8, 2020 · Class II · Z-0738-2021: There is a potential for a defect on the seal of the outer pouch of catheters. The defect may compromise the sterility of the pouch contents, which may increase the risk of post-operative infection, r
- Dec 8, 2020 · Class II · Z-0740-2021: There is a potential for a defect on the seal of the outer pouch of catheters. The defect may compromise the sterility of the pouch contents, which may increase the risk of post-operative infection, r
- Dec 8, 2020 · Class II · Z-0739-2021: There is a potential for a defect on the seal of the outer pouch of catheters. The defect may compromise the sterility of the pouch contents, which may increase the risk of post-operative infection, r

## Indications for use
The Medtronic ARES™ Antibiotic-Impregnated Catheters are intended for use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.

Source page: https://510kreport.com/device/K110560
Methodology: https://510kreport.com/methodology