# K031123: Codman Bactiseal Barium Striped Catheters

- Pathway: 510(k) (Special)
- Applicant: Codman & Shurtleff, Inc.
- Decided: May 14, 2003 after 35 days
- Product code: HCA (Catheter, Ventricular)
- Device class: 2
- Regulation: 21 CFR 882.4100
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Codman BACTISEAL Catheters: named in the summary without a submission number
- (no number) Uni-Shunt Catheters with Elliptical Reservoir: named in the summary without a submission number
- (no number) CODMAN HAKIM Shunt Systems: named in the summary without a submission number

## Most influential descendants
- K090348: Codman Bactiseal Evd Catheter Set, Codman Bactiseal Clear Evd Catheter Set (2009), 2 descendants of its own
- K233445: Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter (2024), 1 descendant of its own
- K233448: Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set (2023), 1 descendant of its own
- K243531: Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology (2025), 0 descendants 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

## Recalls of this device
- Mar 17, 2021 · Class II · Z-1354-2021: Incorrect labeling, Catheter did not have the required holes and markings

## Indications for use
Codman BACTISEAL Barium Striped 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/K031123
Methodology: https://510kreport.com/methodology