# K102589: Codman Bactiseal Catheters, Codman Bactiseal Evd Catheter

- Pathway: 510(k) (Special)
- Applicant: Codman & Shurtleff, Inc.
- Decided: Jan 14, 2011 after 127 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 K003322 (2001). 2 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 7 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.
- K021653: Codman Bactiseal Evd Catheter Set, Codman & Shurtleff, Inc. (2002) Summary page 1.

## Most influential descendants
- K172022: CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled) (2017), 3 descendants of its own
- K233445: Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter (2024), 1 descendant of its own
- K243531: Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology (2025), 0 descendants of its own
- K221840: Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves (2022), 0 descendants of its own

## Indications for use
Codman@T BACTISEAL® EVD Catheter Set is indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume. CODMAN® HAKIM@ BACTISEAL® Ventricular Catheter and Distal Catheter Kit with Bactiseal Shunt System is for use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated. CODMAN® HAKIM® BACTISEAL® Ventricular Catheter with Bactiseal Shunt System is for use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated. CODMAN® HAKIM® BACTISEAL® Distal Catheter Kit with Bactiscal Shunt System is 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/K102589
Methodology: https://510kreport.com/methodology