Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart E — Cardiovascular Surgical Devices](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices) → [21 CFR 870.4240](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4240) → DTR — Heat-Exchanger, Cardiopulmonary Bypass # DTR · Heat-Exchanger, Cardiopulmonary Bypass _Cardiovascular · 21 CFR 870.4240 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTR ## Overview - **Product Code:** DTR - **Device Name:** Heat-Exchanger, Cardiopulmonary Bypass - **Regulation:** [21 CFR 870.4240](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4240) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **Life-sustaining:** yes ## Identification A cardiopulmonary bypass heat exchanger is a device, consisting of a heat exchange system used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 91) Showing 20 most recent of 91 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K252541](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTR/K252541.md) | Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W | Spectrum Medical S.R.L. | Mar 12, 2026 | SESE | | [K240908](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTR/K240908.md) | Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM) | Spectrum Medical , Ltd. | Jul 8, 2025 | SESE | | [K250150](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTR/K250150.md) | VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini) | Sorin Group Italia S.R.L. | May 30, 2025 | SESE | | [K240190](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTR/K240190.md) | MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated | Medtronic | Feb 23, 2024 | SESE | | [K223879](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTR/K223879.md) | Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M) | Quara S.R.L. | Apr 13, 2023 | SESE | | [K220110](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTR/K220110.md) | Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger | Qura S.R.L | May 6, 2022 | SESE | | [K212688](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTR/K212688.md) | Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger | Qura S.R.L | Jan 10, 2022 | SESE | | [K201984](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTR/K201984.md) | MPS 3 ND Myocardial Protection System | Quest Medical, Inc. | Nov 20, 2020 | SESE | | [K200438](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTR/K200438.md) | MPS 3 Myocardial Protection System | Quest Medical, Inc. | Jun 19, 2020 | SESE | | [K173716](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTR/K173716.md) | MPS2 Myocardial Protection System Console | Quest Medical, Inc. | Oct 1, 2018 | SESE | | [K162774](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTR/K162774.md) | MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface (Bridge System) | Medtronic, Inc. | Feb 10, 2017 | SESE | | [K162958](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTR/K162958.md) | MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface; MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface with Bridge; MYOtherm XP Cardioplegia Delivery System; MYOtherm XP Cardioplegia Delivery System with Bridge | Medtronic, Inc. | Feb 1, 2017 | SESE | | [K090555](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTR/K090555.md) | PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, MODEL BIO-CHX 30 | Maquet Cardiopulmonary, AG | Dec 23, 2009 | SESE | | [K081838](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTR/K081838.md) | GISH VISION BLOOD CARDIOPLEGIA WITH HA COATING | Gish Biomedical, Inc. | Jan 26, 2009 | SESE | | [K072583](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTR/K072583.md) | PLEGIOX CARDIOPLEGIA HEAT EXCHANGER, WITH SAFELINE COATING, MODEL(S) CHX30, BSQ-CHX 30 | Maquet Cardiopulmonary, AG | Apr 4, 2008 | SESE | | [K041979](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTR/K041979.md) | MPS MYOCARDIAL PROTECTION SYSTEM - MPS 2 CONSOLE, MODEL 5201260 | Quest Medical, Inc. | Sep 2, 2004 | SESE | | [K040355](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTR/K040355.md) | VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPORAL HEAT EXCHANGER WITH GBS COATING | Gish Biomedical, Inc. | Mar 15, 2004 | SESE | | [K032068](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTR/K032068.md) | CARDIOVENTION CORX IOS-200 SYSTEM, MODEL IOS-200 | Cardiovention, Inc. | Aug 22, 2003 | SESE | | [K021830](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTR/K021830.md) | SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM | Cobe Cardiovascular, Inc. | Jul 2, 2002 | SESE | | [K020106](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTR/K020106.md) | VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPOREAL HEAT EXCHANGER | Gish Biomedical, Inc. | Apr 10, 2002 | SESE | ## Top Applicants - Shiley, Inc. — 11 clearances - Gish Biomedical, Inc. — 10 clearances - 3M Health Care, Sarns — 6 clearances - Quest Medical, Inc. — 5 clearances - Medtronic Vascular — 4 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTR](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTR) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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