The THERMOGARD is an integrated electro-mechanical heater/cooler that consists of a temperature monitor, a temperature controller unit, a heat exchanger unit, and roller pump. It supplies temperature controlled sterile saline to the indwelling Catheter that is placed percutaneously in the patient.

An endovascular catheter having a heat exchange element at the distal end, through which a thermal transfer fluid is circulated to cool or warm the blood, and which has 10.7 Fr diameter.

An endovascular catheter having a heat exchange element at the distal end, through which a thermal transfer fluid is circulated to cool or warm the blood, and which has 14 Fr diameter.

The InnerCool Accutrol® Catheter contains an integrated thermistor for temperature feedback and control that eliminates the need for an independently placed temperature-monitoring probe. The Catheter has a polymeric catheter shaft with a radio-opaque flexible distal metallic Temperature Control Element (TCE).

The InnerCool Accutrol® Catheter contains an integrated thermistor for temperature feedback and control that eliminates the need for an independently placed temperature-monitoring probe. The Catheter has a polymeric catheter shaft with a radio-opaque flexible distal metallic Temperature Control Element (TCE).

An endovascular catheter having a heat exchange element at the distal end, through which a thermal transfer fluid is circulated to cool or warm the blood, and which has 14 Fr diameter.

An endovascular catheter having a heat exchange element at the distal end, through which a thermal transfer fluid is circulated to cool or warm the blood, and which has 10.7 Fr diameter.

The InnerCool RTx Circulating Cassette is part of the InnerCool RTx Endovascular Cooling System. It cools the heat-transfer fluid that circulates through the Cassette and Catheters.

The InnerCool RTx Circulating Cassette is part of the InnerCool RTx Endovascular Cooling System. It cools the heat-transfer fluid that circulates through the Cassette and Catheters.

The ZOLL® Intravascular Temperature Management (IVTM™) System is comprised of an external heat exchange console (Thermogard HQ™ console) and intravascular heat exchange catheter connected via a sterile heat exchanger and tubing circuit (Thermogard HQTM Start-Up Kit or Thermogard HQTM Start-Up Kit EX). These components together comprise a patient temperature regulation apparatus employing feedback control. The subject devices of this submission are the proposed Thermogard HQTM Console, Thermogard HQTM Start-Up Kit and Thermogard HQTM Start-Up Kit EX.

The ZOLL® Intravascular Temperature Management (IVTM™) System is comprised of an external heat exchange console (Thermogard HQ™ console) and intravascular heat exchange catheter connected via a sterile heat exchanger and tubing circuit (Thermogard HQTM Start-Up Kit or Thermogard HQTM Start-Up Kit EX). These components together comprise a patient temperature regulation apparatus employing feedback control. The subject devices of this submission are the proposed Thermogard HQTM Console, Thermogard HQTM Start-Up Kit and Thermogard HQTM Start-Up Kit EX.

The ZOLL® Intravascular Temperature Management (IVTM™) System is comprised of an external heat exchange console (Thermogard HQ™ console) and intravascular heat exchange catheter connected via a sterile heat exchanger and tubing circuit (Thermogard HQTM Start-Up Kit or Thermogard HQTM Start-Up Kit EX). These components together comprise a patient temperature regulation apparatus employing feedback control. The subject devices of this submission are the proposed Thermogard HQTM Console, Thermogard HQTM Start-Up Kit and Thermogard HQTM Start-Up Kit EX.

Hospital Monitoring Interface Accessory (HIMIA) 8 Pin provides patient temperature signal from the Alsius System to a bedside patient monitoring system.

The Cool Line® Heat Exchange Catheter is a 9.3 Fr, 22 cm, triple infusion lumen catheter designed for placement in the central venous circulation from an insertion site in the jugular, subclavian, or femoral veins.

The Icy® Heat Exchange Catheter is a sterile, single use flexible 9.3 F catheter designed for placement in the inferior vena cava from an insertion site in the femoral vein.

The Icy® Heat Exchange Catheter is a sterile, single use flexible 9.3 F catheter designed for placement in the inferior vena cava from an insertion site in the femoral vein.

The Quattro Heat Exchange Heat Catheter is a 9.3 Fr, 45 cm, triple infusion lumen catheter designed for placement in the inferior vena cava from an insertion site in the femoral vein.

The Quattro Heat Exchange Heat Catheter is a 9.3 Fr, 45 cm, triple infusion lumen catheter designed for placement in the inferior vena cava from an insertion site in the femoral vein.

6 foot tubing set including integral air trap chamber and stainless steel heat exchange coil

9 foot tubing set including integral air trap chamber and stainless steel heat exchange coil

The Solex Catheter is a 9.3 F, 26 cm, triple infusion lumen catheter designed for placement in the superior vena cava from an insertion site in the jugular vein.

The Solex Catheter is a 9.3 F, 26 cm, triple infusion lumen catheter designed for placement in the superior vena cava from an insertion site in the jugular vein.

The Icy® Heat Exchange Catheter is a sterile, single use flexible 9.3 F catheter designed for placement in the inferior vena cava from an insertion site in the femoral vein.

The Quattro Heat Exchange Heat Catheter is a 9.3 Fr, 45 cm, triple infusion lumen catheter designed for placement in the inferior vena cava from an insertion site in the femoral vein.

The Icy® Heat Exchange Catheter is a sterile, single use flexible 9.3 F catheter designed for placement in the inferior vena cava from an insertion site in the femoral vein.

The Quattro Heat Exchange Heat Catheter is a 9.3 Fr, 45 cm, triple infusion lumen catheter designed for placement in the inferior vena cava from an insertion site in the femoral vein.

The Cool Line® Heat Exchange Catheter is a 9.3 Fr, 22 cm, triple infusion lumen catheter designed for placement in the central venous circulation from an insertion site in the jugular, subclavian, or femoral veins.

The Cool Line® Heat Exchange Catheter is a 9.3 Fr, 22 cm, triple infusion lumen catheter designed for placement in the central venous circulation from an insertion site in the jugular, subclavian, or femoral veins.

The Cool Line® Heat Exchange Catheter is a 9.3 Fr, 22 cm, triple infusion lumen catheter designed for placement in the central venous circulation from an insertion site in the jugular, subclavian, or femoral veins.

The Icy® Heat Exchange Catheter is a sterile, single use flexible 9.3 F catheter designed for placement in the inferior vena cava from an insertion site in the femoral vein.

The Icy® Heat Exchange Catheter is a sterile, single use flexible 9.3 F catheter designed for placement in the inferior vena cava from an insertion site in the femoral vein.

The Icy® Heat Exchange Catheter is a sterile, single use flexible 9.3 F catheter designed for placement in the inferior vena cava from an insertion site in the femoral vein.

The Quattro Heat Exchange Heat Catheter is a 9.3 Fr, 45 cm, triple infusion lumen catheter designed for placement in the inferior vena cava from an insertion site in the femoral vein.

The Quattro Heat Exchange Heat Catheter is a 9.3 Fr, 45 cm, triple infusion lumen catheter designed for placement in the inferior vena cava from an insertion site in the femoral vein.

The Quattro Heat Exchange Heat Catheter is a 9.3 Fr, 45 cm, triple infusion lumen catheter designed for placement in the inferior vena cava from an insertion site in the femoral vein.

6 foot tubing set including integral air trap chamber and stainless steel heat exchange coil

9 foot tubing set including integral air trap chamber and stainless steel heat exchange coil

The Cool Line® Heat Exchange Catheter is a 9.3 Fr, 22 cm, triple infusion lumen catheter designed for placement in the central venous circulation from an insertion site in the jugular, subclavian, or femoral veins.

The Icy® Heat Exchange Catheter is a sterile, single use flexible 9.3 F catheter designed for placement in the inferior vena cava from an insertion site in the femoral vein.

The Quattro Heat Exchange Heat Catheter is a 9.3 Fr, 45 cm, triple infusion lumen catheter designed for placement in the inferior vena cava from an insertion site in the femoral vein.

The Quattro Heat Exchange Heat Catheter is a 9.3 Fr, 45 cm, triple infusion lumen catheter designed for placement in the inferior vena cava from an insertion site in the femoral vein.

The Solex Catheter is a 9.3 F, 26 cm, triple infusion lumen catheter designed for placement in the superior vena cava from an insertion site in the jugular vein.

The Solex Catheter is a 9.3 F, 26 cm, triple infusion lumen catheter designed for placement in the superior vena cava from an insertion site in the jugular vein.

The Solex Catheter is a 9.3 F, 26 cm, triple infusion lumen catheter designed for placement in the superior vena cava from an insertion site in the jugular vein.

Hospital Monitoring Interface Accessory (HIMIA) 8 Pin provides patient temperature signal from the Alsius System to a bedside patient monitoring system.

The Cool Line® Heat Exchange Catheter is a 9.3 Fr, 22 cm, triple infusion lumen catheter designed for placement in the central venous circulation from an insertion site in the jugular, subclavian, or femoral veins.

The THERMOGARD is an integrated electro-mechanical heater/cooler that consists of a temperature monitor, a temperature controller unit, a heat exchanger unit, and roller pump. It supplies temperature controlled sterile saline to the indwelling Catheter that is placed percutaneously in the patient.

The THERMOGARD is an integrated electro-mechanical heater/cooler that consists of a temperature monitor, a temperature controller unit, a heat exchanger unit, and roller pump. It supplies temperature controlled sterile saline to the indwelling Catheter that is placed percutaneously in the patient.

The THERMOGARD is an integrated electro-mechanical heater/cooler that consists of a temperature monitor, a temperature controller unit, a heat exchanger unit, and roller pump. It supplies temperature controlled sterile saline to the indwelling Catheter that is placed percutaneously in the patient.

The THERMOGARD is an integrated electro-mechanical heater/cooler that consists of a temperature monitor, a temperature controller unit, a heat exchanger unit, and roller pump. It supplies temperature controlled sterile saline to the indwelling Catheter that is placed percutaneously in the patient.