# K052443: Icy Catheter, Model IC-3893A

- Pathway: 510(k) (Traditional)
- Applicant: Alsius Corp.
- Decided: Oct 17, 2005 after 41 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: 4 generations back to K811742 (1981). 15 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030421: Alsius Coolgard 3000 & Alsius Catheter System, Alsius Corp. (2003) Summary page 1.

## Most influential descendants
- K070161: Quattro Catheter Model IC4593 (2007), 7 descendants of its own
- K101987: Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro Catheter, Model IC-4593 (2010), 6 descendants of its own
- 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

## Indications for use
The Icy™ Catheter Model IC-3893A, connected to the COOLGARD 3000/Alsius Catheter 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.

Source page: https://510kreport.com/device/K052443
Methodology: https://510kreport.com/methodology