# K021653: Codman Bactiseal Evd Catheter Set

- Pathway: 510(k) (Traditional)
- Applicant: Codman & Shurtleff, Inc.
- Decided: Jul 29, 2002 after 70 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
No predicates in its family tree.
8 later devices descend from it; 3 cite it directly.
0 of 9 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) Codman External Drainage Ventricular Catheter Set: named in the summary without a submission number
- (no number) Cook Inc. SPECTRUM Ventricular Catheter: named in the summary without a submission number

## Most influential descendants
- K102589: Codman Bactiseal Catheters, Codman Bactiseal Evd Catheter (2011), 4 descendants of its own
- K172022: CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled) (2017), 3 descendants of its own
- 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

## Indications for use
The Codman BACTISEALTM 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.

Source page: https://510kreport.com/device/K021653
Methodology: https://510kreport.com/methodology