Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart E — Cardiovascular Surgical Devices](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices) → [21 CFR 870.4250](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4250) → DWC — Controller, Temperature, Cardiopulmonary Bypass # DWC · Controller, Temperature, Cardiopulmonary Bypass _Cardiovascular · 21 CFR 870.4250 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWC ## Overview - **Product Code:** DWC - **Device Name:** Controller, Temperature, Cardiopulmonary Bypass - **Regulation:** [21 CFR 870.4250](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4250) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **Life-sustaining:** yes ## Identification A cardiopulmonary bypass temperature controller is a device used to control the temperature of the fluid entering and leaving a heat exchanger. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 30) Showing 20 most recent of 30 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K220635](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWC/K220635.md) | Heater-Cooler System 3T | Livanova Deutschland, GmbH | Nov 16, 2022 | SESE | | [K212657](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWC/K212657.md) | Quantum Heater-Cooler | Spectrum Medical , Ltd. | May 6, 2022 | SESE | | [K191402](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWC/K191402.md) | Heater-Cooler System 3T | Livanova Deutschland, GmbH | Feb 25, 2020 | SESE | | [K140012](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWC/K140012.md) | SORIN FLEXTHERM | Sorin Group Deutschland GmbH | Jan 31, 2014 | SESE | | [K130300](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWC/K130300.md) | HEATER-COOLER UNIT HCU 40 | Maquet Cardiopulmonary, AG | Jul 1, 2013 | SESE | | [K122813](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWC/K122813.md) | HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM | Cincinnati Sub-Zero Products, Inc. | Dec 18, 2012 | SESE | | [K102147](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWC/K102147.md) | CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000 | Cardioquip Llp | Nov 19, 2010 | SESE | | [K071521](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWC/K071521.md) | TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM | Terumo Cardiovascular Systems Corp. | Nov 21, 2007 | SESE | | [K052601](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWC/K052601.md) | STOCKERT HEATER-COOLER SYSTEM 3T | Sorin Group Deutschland GmbH | Jun 6, 2006 | SESE | | [K031544](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWC/K031544.md) | HEATER COOLER UNIT, MODEL HCU 30 | Jostra AB | Aug 7, 2003 | SESE | | [K014016](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWC/K014016.md) | ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER | Minntech Corp. | Feb 1, 2002 | SESE | | [K003145](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWC/K003145.md) | ORIGEN BLADDER HOLDER | Origen Biomedical, Inc. | Apr 20, 2001 | SESE | | [K001520](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWC/K001520.md) | ALPHA OMEGA DUAL COOLER-HEATER | Alpha Omega, Inc. | Nov 22, 2000 | SESE | | [K945720](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWC/K945720.md) | JOSTRA HL-15 MODULAR HEART-LUNG MACHINE (HEREINAFTER CALLED THE HL-15 OR THE DEVICE | Jostra Bentley | Mar 29, 1995 | SESE | | [K896975](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWC/K896975.md) | CARDIAC COOLING JACKET, 30% REDUCED, MODEL CJ-220 | Daily Medical Products, Inc. | Feb 5, 1990 | SESE | | [K896974](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWC/K896974.md) | CARDIAC COOLING JACKET, 8 CM, MODEL CJ-120 | Daily Medical Products, Inc. | Feb 5, 1990 | SESE | | [K896973](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWC/K896973.md) | CARDIAC COOLING JACKET, 30% ENLARGED, MODEL CJ-320 | Daily Medical Products, Inc. | Feb 5, 1990 | SESE | | [K896972](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWC/K896972.md) | CARDIAC COOLING JACKET, 12 CM, MODEL CJ-520 | Daily Medical Products, Inc. | Feb 5, 1990 | SESE | | [K896971](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWC/K896971.md) | CARDIAC COOLING JACKET, 8 CM, MODEL CJ-420 | Daily Medical Products, Inc. | Feb 5, 1990 | SESE | | [K896393](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWC/K896393.md) | CARDIAC COOLING JACKED, 16 CM, MODEL CJ-620 | Daily Medical, Inc. | Feb 2, 1990 | SESE | ## Top Applicants - Daily Medical Products, Inc. — 5 clearances - Sorin Group Deutschland GmbH — 2 clearances - Livanova Deutschland, GmbH — 2 clearances - Gambro, Inc. — 2 clearances - 3M Health Care, Sarns — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWC](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWC) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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