# 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

- Pathway: 510(k) (Traditional)
- Applicant: Zoll Circulation, Inc.
- Decided: Dec 20, 2021 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: 9 generations back to K811742 (1981). 33 ancestors in all.
2 later devices descend from it; 2 cite it directly.
3 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072234: Thermogard XP Thermal Regulation System, Alsius Corp. (2007) Summary page 6.
- K060308: Coolgard 3000, Alsius Corp. (2006) Summary page 6.
- K150046: Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Zoll Circulation, Inc. (2015) Summary page 6.
- K153226: Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit, Zoll Circulation, Inc. (2016) Summary page 6.

## Most influential descendants
- 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
- K223746: Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard XP Console, Thermogard HQ Console (2023), 0 descendants of its own

## Indications for use
The Solex 7 Intravascular Heat Exchange Catheter connected to the Coolgard/Thermogard Thermal Regulation System is indicated for use: • In cardiac surgery patients to achieve and/or maintain normothermia during surgery and recovery/intensive care. (Maximum use period: 4 days) • To induce, maintain and reverse mild hypothermia in neurosurgery patients in surgery and recovery/intensive care. (Maximum use period: 4 days) • In fever reduction, as an adjunct to other 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. (Maximum use period: 7 days) 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 Intravascular Heat Exchange Catheter Model IC-3893A, connected to the ZOLL Coolgard/Thermogard 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 Model 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/K213031
Methodology: https://510kreport.com/methodology