# K090348: Codman Bactiseal Evd Catheter Set, Codman Bactiseal Clear Evd Catheter Set

- Pathway: 510(k) (Special)
- Applicant: Codman & Shurtleff, Inc.
- Decided: Mar 4, 2009 after 21 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 K021653 (2002). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021653: Codman Bactiseal Evd Catheter Set, Codman & Shurtleff, Inc. (2002) Summary page 1.
- K031123: Codman Bactiseal Barium Striped Catheters, Codman & Shurtleff, Inc. (2003) Summary page 1.

## Most influential descendants
- K233448: Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set (2023), 1 descendant of its own
- K243552: Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libertís™ 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762) (2025), 0 descendants of its own

## Indications for use
Codman® BACTISEAL® EVD Catheter Set and Codman® BACTISEAL® Clear EVD Catheter Set are 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.

Source page: https://510kreport.com/device/K090348
Methodology: https://510kreport.com/methodology