# K013182: Triple Lumen Central Venous Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cook, Inc.
- Decided: Jul 1, 2002 after 280 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K820648 (1982). 5 ancestors in all.
No later device cites it as a predicate yet.
3 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970864: Arrow-Howes Large Bore Multi-Lumen Central Venous Catheters, Arrow Intl., Inc. (1997) Summary page 1.
- (no number) Cook Double Lumen Catheters: named in the summary without a submission number

## Indications for use
A vascular access catheter used for, infusion and withdrawat of brood, blood products, and ff uids, central venous blood pressure monitoring (CVP), acute hyperalimentation, continuous or intermittent drug infusion.

Source page: https://510kreport.com/device/K013182
Methodology: https://510kreport.com/methodology