# K032274: Cook Five Lumen Central Venous Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cook, Inc.
- Decided: Feb 26, 2004 after 218 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 K960764 (1997). 4 ancestors in all.
33 later devices descend from it; 2 cite it directly.
1 of 38 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984189: Argon Multi-Lumen Central Venous Catheter, Maxxim Medical (1999) Summary page 1.
- K010021: Medcomp Quad Lumen, 8.5F X 20CM, Model MC4L-8S, Medical Components, Inc. (2001) Summary page 1.
- K904404: Multi-Lumen Central Venous Catheter Set, Arrow Intl., Inc. (1991) Summary page 1.
- (no number) Central Venous Catheter: named in the summary without a submission number

## Most influential descendants
- K060174: Spectrum Five Lumen Central Venous Catheter Set, Model C-UQLM10.0-Abrm (2006), 32 descendants of its own
- K081113: Cook and Cook Spectrum Central Venous Catheters (2008), 31 descendants of its own
- K101326: NMI IC (2010), 26 descendants of its own
- K121089: Nmi Picc Iii (2012), 23 descendants of its own
- K111906: Xcela Hybrid Picc with Pasv Valve Technology (2011), 14 descendants of its own

## Indications for use
The Five Lumen Central Venous Catheter is used for the intravenous administration of nutrien; fluids, chemotherapeutic agents and other drugs for therapy, blood sampling, blood delivery, and venous pressure monitoring. The catheter is intended for short-term vascular access.

Source page: https://510kreport.com/device/K032274
Methodology: https://510kreport.com/methodology