# K003322: Codman Bactiseal Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Codman & Shurtleff, Inc.
- Decided: Oct 1, 2001 after 342 days
- Product code: HCA (Catheter, Ventricular)
- Device class: 2
- Regulation: 21 CFR 882.4100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
13 later devices descend from it; 4 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K020667: Codman Hakim Shunt Systems (2002), 8 descendants of its own
- K053350: Modification to Codman Hakim Shunt Systems (2006), 5 descendants of its own
- K122118: Hakim Programmable and Precision Valve Shunt System (2012), 4 descendants of its own
- 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

Source page: https://510kreport.com/device/K003322
Methodology: https://510kreport.com/methodology