# K141139: Solex Intravascular Heat Exchange Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Zoll Circulation
- Decided: Oct 3, 2014 after 154 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: 7 generations back to K811742 (1981). 28 ancestors in all.
4 later devices descend from it; 1 cites 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)
- K081936: Solex Catheter, Model SL2593, Alsius Corp. (2008) Summary page 4.
- K101987: Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro Catheter, Model IC-4593, Zoll Circulation (2010) Summary page 4.

## Most influential descendants
- 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
- 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 Intravascular Heat Exchange Catheter connected to the CoolGuard 3000/Thermogard XP Thermal Regulation System is indicated for use: In cardiac surgery patients to achieve and/or maintain normothermia during surgery and recovery/intensive care, and to induce, maintain and reverse mild hypothermia in neurosurgery patients in surgery and recovery/intensive care. Maximum use period: 48 hours.

Source page: https://510kreport.com/device/K141139
Methodology: https://510kreport.com/methodology