# K233448: Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set

- Pathway: 510(k) (Traditional)
- Applicant: Integra Lifesciences Production Corporation
- Decided: Dec 19, 2023 after 60 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: 2 generations back to K021653 (2002). 3 ancestors in all.
1 later device descends 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 5.
- K090348: Codman Bactiseal Evd Catheter Set, Codman Bactiseal Clear Evd Catheter Set, Codman & Shurtleff, Inc. (2009) Summary page 5.

## Most influential descendants
- 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

## Recalls of this device
- May 7, 2024 · Class II · Z-2138-2024: Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility.
- May 7, 2024 · Class II · Z-2136-2024: Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal that may compromise the product sterility.
- May 7, 2024 · Class II · Z-2137-2024: Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility.

## Indications for use
The Bactiseal EVD Catheter and Bactiseal Clear EVD Catheter sets 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/K233448
Methodology: https://510kreport.com/methodology