DTR · Heat-Exchanger, Cardiopulmonary Bypass
Cardiovascular · 21 CFR 870.4240 · Class 2
Overview
| Product Code | DTR |
|---|---|
| Device Name | Heat-Exchanger, Cardiopulmonary Bypass |
| Regulation | 21 CFR 870.4240 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 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 | Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W | Spectrum Medical S.R.L. | Mar 12, 2026 | SESE |
| K240908 | Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM) | Spectrum Medical , Ltd. | Jul 8, 2025 | SESE |
| K250150 | 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 | MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated | Medtronic | Feb 23, 2024 | SESE |
| K223879 | Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M) | Quara S.R.L. | Apr 13, 2023 | SESE |
| K220110 | Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger | Qura S.R.L | May 6, 2022 | SESE |
| K212688 | Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger | Qura S.R.L | Jan 10, 2022 | SESE |
| K201984 | MPS 3 ND Myocardial Protection System | Quest Medical, Inc. | Nov 20, 2020 | SESE |
| K200438 | MPS 3 Myocardial Protection System | Quest Medical, Inc. | Jun 19, 2020 | SESE |
| K173716 | MPS2 Myocardial Protection System Console | Quest Medical, Inc. | Oct 1, 2018 | SESE |
| K162774 | 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 | 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 | PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, MODEL BIO-CHX 30 | Maquet Cardiopulmonary, AG | Dec 23, 2009 | SESE |
| K081838 | GISH VISION BLOOD CARDIOPLEGIA WITH HA COATING | Gish Biomedical, Inc. | Jan 26, 2009 | SESE |
| K072583 | PLEGIOX CARDIOPLEGIA HEAT EXCHANGER, WITH SAFELINE COATING, MODEL(S) CHX30, BSQ-CHX 30 | Maquet Cardiopulmonary, AG | Apr 4, 2008 | SESE |
| K041979 | MPS MYOCARDIAL PROTECTION SYSTEM - MPS 2 CONSOLE, MODEL 5201260 | Quest Medical, Inc. | Sep 2, 2004 | SESE |
| K040355 | VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPORAL HEAT EXCHANGER WITH GBS COATING | Gish Biomedical, Inc. | Mar 15, 2004 | SESE |
| K032068 | CARDIOVENTION CORX IOS-200 SYSTEM, MODEL IOS-200 | Cardiovention, Inc. | Aug 22, 2003 | SESE |
| K021830 | SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM | Cobe Cardiovascular, Inc. | Jul 2, 2002 | SESE |
| K020106 | 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
