DTR — Heat-Exchanger, Cardiopulmonary Bypass Class II
FDA Device Classification
Classification Details
- Product Code
- DTR
- Device Class
- Class II
- Regulation Number
- 870.4240
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K252541 | spectrum medical | Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W | March 12, 2026 |
| K240908 | spectrum medical | Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery | July 8, 2025 |
| K250150 | sorin group italia | VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGU | May 30, 2025 |
| K240190 | medtronic | MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOther | February 23, 2024 |
| K223879 | quara | Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M) | April 13, 2023 |
| K220110 | qura | Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat | May 6, 2022 |
| K212688 | qura | Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exc | January 10, 2022 |
| K201984 | quest medical | MPS 3 ND Myocardial Protection System | November 20, 2020 |
| K200438 | quest medical | MPS 3 Myocardial Protection System | June 19, 2020 |
| K173716 | quest medical | MPS2 Myocardial Protection System Console | October 1, 2018 |
| K162774 | medtronic | MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOther | February 10, 2017 |
| K162958 | medtronic | MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface; MYOtherm XP C | February 1, 2017 |
| K090555 | maquet cardiopulmonary | PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, MODEL BIO-CHX 30 | December 23, 2009 |
| K081838 | gish biomedical | GISH VISION BLOOD CARDIOPLEGIA WITH HA COATING | January 26, 2009 |
| K072583 | maquet cardiopulmonary | PLEGIOX CARDIOPLEGIA HEAT EXCHANGER, WITH SAFELINE COATING, MODEL(S) CHX30, BSQ- | April 4, 2008 |
| K041979 | quest medical | MPS MYOCARDIAL PROTECTION SYSTEM - MPS 2 CONSOLE, MODEL 5201260 | September 2, 2004 |
| K040355 | gish biomedical | VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPORAL HEAT EXCHANGER WITH GBS COATI | March 15, 2004 |
| K032068 | cardiovention | CARDIOVENTION CORX IOS-200 SYSTEM, MODEL IOS-200 | August 22, 2003 |
| K021830 | cobe cardiovascular | SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM | July 2, 2002 |
| K020106 | gish biomedical | VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPOREAL HEAT EXCHANGER | April 10, 2002 |