DTR — Heat-Exchanger, Cardiopulmonary Bypass Class II
FDA product code DTR covers "Heat-Exchanger, Cardiopulmonary Bypass", a Class II medical device regulated under 21 CFR 870.4240. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |