# K261004: Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684)

- Pathway: 510(k) (Traditional)
- Applicant: Integra Lifesciences Production Corporation
- Decided: Jun 23, 2026 after 89 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.
No later device cites it as a predicate yet.
0 of 1 device 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® Distal Peritoneal Catheter, Barium Open End - Preamendment: named in the summary without a submission number
- (no number) Codman® HOLTER® Peritoneal Catheter (SALMON Design) - Preamendment: named in the summary without a submission number

## Indications for use
Codman® Distal Peritoneal Catheter, Barium Open End is indicated for use with a proximal valve in the treatment of hydrocephalus where ventriculoperitoneal shunting is the procedure of choice. The HOLTER Peritoneal Catheter (SALMON Design) is indicated for use with a HOLTER Valve in the treatment of hydrocephalus where the ventriculoperitoneal shunting technique is the procedure of choice.

Source page: https://510kreport.com/device/K261004
Methodology: https://510kreport.com/methodology