Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart F — Cardiovascular Therapeutic Devices](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices) → [21 CFR 870.5900](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/870.5900) → NCX — System, Hypothermia, Intravenous, Cooling # NCX · System, Hypothermia, Intravenous, Cooling _Cardiovascular · 21 CFR 870.5900 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/NCX ## Overview - **Product Code:** NCX - **Device Name:** System, Hypothermia, Intravenous, Cooling - **Regulation:** [21 CFR 870.5900](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/870.5900) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) ## Identification A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 26) Showing 20 most recent of 26 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K223746](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/NCX/K223746.md) | 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 | Zoll Circulation, Inc. | Jan 13, 2023 | SESU | | [K220008](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/NCX/K220008.md) | 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 | Zoll Circulation, Inc. | Jun 2, 2022 | SESU | | [K213031](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/NCX/K213031.md) | 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 | Zoll Circulation, Inc. | Dec 20, 2021 | SESU | | [K152946](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/NCX/K152946.md) | TEMPEDY | Seiratherm GmbH | Sep 15, 2016 | SESE | | [K153162](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/NCX/K153162.md) | Hypocore | Novocor Medical Systems, Inc. | May 24, 2016 | SESE | | [K153226](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/NCX/K153226.md) | Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit | Zoll Circulation, Inc. | Mar 24, 2016 | SESU | | [K150046](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/NCX/K150046.md) | Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter | Zoll Circulation, Inc. | Oct 30, 2015 | SESU | | [K141139](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/NCX/K141139.md) | SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER | Zoll Circulation | Oct 3, 2014 | SESE | | [K101987](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/NCX/K101987.md) | COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO CATHETER, MODEL IC-4593 | Zoll Circulation | Oct 12, 2010 | SESU | | [K080908](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/NCX/K080908.md) | INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM | Innercool Therapies, Inc.- A Delaware Corporation | Oct 17, 2008 | SESE | | [K081936](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/NCX/K081936.md) | SOLEX CATHETER, MODEL SL2593 | Alsius Corp. | Aug 13, 2008 | SESE | | [K080899](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/NCX/K080899.md) | ARCTIC BLAST INTRAVENOUS FLUID CHILLER | Medivance, Inc. | Aug 7, 2008 | SESE | | [K072234](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/NCX/K072234.md) | THERMOGARD XP THERMAL REGULATION SYSTEM | Alsius Corp. | Aug 23, 2007 | SESE | | [K071358](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/NCX/K071358.md) | REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM | Radiant Medical | Jun 1, 2007 | SESE | | [K071008](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/NCX/K071008.md) | REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM | Radiant Medical | May 9, 2007 | SESU | | [K070161](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/NCX/K070161.md) | QUATTRO CATHETER MODEL IC4593 | Alsius Corp. | Feb 15, 2007 | SESE | | [K063829](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/NCX/K063829.md) | THERMOGARD THERMAL REGULATION SYSTEM | Alsius Corp. | Jan 22, 2007 | SESU | | [K063405](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/NCX/K063405.md) | REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM | Radiant Medical | Jan 8, 2007 | SESE | | [K060308](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/NCX/K060308.md) | COOLGARD 3000 | Alsius Corp. | Apr 26, 2006 | SESU | | [K052443](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/NCX/K052443.md) | ICY CATHETER, MODEL IC-3893A | Alsius Corp. | Oct 17, 2005 | SESE | ## Top Applicants - Alsius Corp. — 9 clearances - Zoll Circulation, Inc. — 5 clearances - Radiant Medical — 4 clearances - Zoll Circulation — 2 clearances - Innercool Therapies — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/NCX](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/NCX) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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