# K101987: Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro Catheter, Model IC-4593

- Pathway: 510(k) (Traditional)
- Applicant: Zoll Circulation
- Decided: Oct 12, 2010 after 90 days
- Product code: NCX (System, Hypothermia, Intravenous, Cooling)
- Device class: 2
- Regulation: 21 CFR 870.5900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K811742 (1981). 26 ancestors in all.
6 later devices descend from it; 3 cite it directly.
3 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014241: Coolgard 3000, Cooline, Start-UP, Models 3000, CL-2085B, CL-2295A, CG-500D, Alsius Corp. (2003)
- K052443: Icy Catheter, Model IC-3893A, Alsius Corp. (2005) Summary page 6.
- K070161: Quattro Catheter Model IC4593, Alsius Corp. (2007) Summary page 6.

## Most influential descendants
- K150046: Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter (2015), 4 descendants of its own
- K141139: Solex Intravascular Heat Exchange Catheter (2014), 4 descendants of its own
- K153226: Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit (2016), 3 descendants of its own
- K213031: Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit, Coolgard 3000 Console, Thermogard XP Console (2021), 2 descendants of its own
- K220008: Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogard HQ Console (2022), 1 descendant of its own

## Indications for use
The Cool Line Catheter Model CL-2295A when used with the ZOLL Thermal Regulation System is indicated for use in fever reduction, as an adjunct to antipyretic therapy, in adult patients with cerebral infarction and intracerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated. The ZOLL ICY Catheter Model IC-3893A, connected to the ZOLL Thermal Regulation System, is indicated for use: + In cardiac surgery adult patients to achieve and/or maintain normothermia during surgery and recovery/intensive care, and + To induce, maintain and reverse mild hypothermia in neurosurgery adult patients in surgery and recovery/intensive care. The ZOLL Quattro Catheter Mode! IC-4593, connected to a ZOLL Thermal Regulation System, is indicated for use: * In cardiac surgery adult patients to achieve and/or maintain normothermia during surgery and recovery/intensive care, and » To induce, maintain and reverse mild hypothermia in neurosurgery adult patients in surgery and recovery/intensive care.

Source page: https://510kreport.com/device/K101987
Methodology: https://510kreport.com/methodology