# K182252: Cook Unimpregnated Central Venous Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: May 17, 2019 after 270 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: 5 generations back to K960764 (1997). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081113: Cook and Cook Spectrum Central Venous Catheters, Cook, Inc. (2008) Summary page 5.

## Most influential descendants
- K260165: Unimpregnated Central Venous Catheter (2026), 0 descendants of its own

## Indications for use
The Cook Unimpregnated Central Venous Catheter (Non-Power Injectable) is used for: 1. Continuous or intermittent drug infusions 2. Central venous blood pressure monitoring (CVP) 3. Acute hyperalimentation 4. Blood sampling 5. Delivery of whole blood or blood products 6. Simultaneous, separate infusion of drugs for multi-lumen catheters only The device is a short-term use catheter, intended for less than 30 days. The Cook dilator is used for dilating puncture sites or catheter tracts. The Cook Unimpregnated Central Venous Catheter (Non-Power Injectable) is intended for adult and pediatric populations. The Cook Unimpregnated Central Venous Catheter with power injection is used for: 1. Continuous or intermittent drug infusions 2. Central venous blood pressure monitoring (CVP) 3. Acute hyperalimentation 4. Blood sampling 5. Delivery of whole blood or blood products 6. Simultaneous, separate infusion of drugs for multi-lumen catheters only 7. Power injection of contrast media* *The flow rate may not exceed 3 mL/sec for 4.0 and 5.0 French catheters and 10 mL/sec for 7.0, 8.0, 9.0, and 10.0 French catheters. Verify prior to use that the maximum safety cut-off pressure limit is set at or below 250 psi for 4.0 and 5.0 French catheters and 325 psi for 7.0, 8.0, 9.0, and 10.0 French catheters. The device is a short-term use catheter, intended for less than 30 days. The 9.0 and 10.0 French catheters include an inner catheter to facilitate insertion of the main catheter. The Cook dilator is used for dilating puncture sites or catheter tracts. The Cook Unimpregnated Central Venous Catheter with power injection is intended for adult and pediatric populations.

Source page: https://510kreport.com/device/K182252
Methodology: https://510kreport.com/methodology