Product code DTR
- Device name
- Heat-Exchanger, Cardiopulmonary Bypass
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.4240
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252541 | Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W | Spectrum Medical S.R.L. | 2026-03-12 |
| K240908 | Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM) | Spectrum Medical , Ltd. | 2025-07-08 |
| 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. | 2025-05-30 |
| K240190 | MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated | Medtronic | 2024-02-23 |
| K223879 | Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M) | Quara S.R.L. | 2023-04-13 |
| K220110 | Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger | Qura S.R.L | 2022-05-06 |
| K212688 | Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger | Qura S.R.L | 2022-01-10 |
| K201984 | MPS 3 ND Myocardial Protection System | Quest Medical, Inc. | 2020-11-20 |
| K200438 | MPS 3 Myocardial Protection System | Quest Medical, Inc. | 2020-06-19 |
| K173716 | MPS2 Myocardial Protection System Console | Quest Medical, Inc. | 2018-10-01 |
| K162774 | MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface (Bridge System) | Medtronic, Inc. | 2017-02-10 |
| 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. | 2017-02-01 |
| K090555 | PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, MODEL BIO-CHX 30 | Maquet Cardiopulmonary, AG | 2009-12-23 |
| K081838 | GISH VISION BLOOD CARDIOPLEGIA WITH HA COATING | Gish Biomedical, Inc. | 2009-01-26 |
| K072583 | PLEGIOX CARDIOPLEGIA HEAT EXCHANGER, WITH SAFELINE COATING, MODEL(S) CHX30, BSQ-CHX 30 | Maquet Cardiopulmonary, AG | 2008-04-04 |
| K041979 | MPS MYOCARDIAL PROTECTION SYSTEM - MPS 2 CONSOLE, MODEL 5201260 | Quest Medical, Inc. | 2004-09-02 |
| K040355 | VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPORAL HEAT EXCHANGER WITH GBS COATING | Gish Biomedical, Inc. | 2004-03-15 |
| K032068 | CARDIOVENTION CORX IOS-200 SYSTEM, MODEL IOS-200 | Cardiovention, Inc. | 2003-08-22 |
| K021830 | SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM | Cobe Cardiovascular, Inc. | 2002-07-02 |
| K020106 | VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPOREAL HEAT EXCHANGER | Gish Biomedical, Inc. | 2002-04-10 |
| K012898 | MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM | Cobe Cardiovascular, Inc. | 2001-09-17 |
| K000977 | COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT - HEAT EXCHANGER COILS | Olson Medical Sales, Inc. | 2001-03-23 |
| K003724 | CBMYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM WITH CARMEDA BIOACTIVE SURFACE, MODELS CB41 AND CB41-B | Medtronic Vascular | 2000-12-21 |
| K991137 | ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER | Minntech Corp. | 2000-06-08 |
| K982467 | CAPIOX CARDIOPLEGIA | Terumo Medical Corp. | 1999-06-23 |
| K973475 | CARMEDA COATED CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS (CBCTXXX SERIES AND CBCTXXXBR SERIES) | Medtronic Vascular | 1997-11-20 |
| K964571 | VISION CARDIOPLEGIA DELIVERY SYSTEM | Lifestream Int'L, Inc. | 1997-08-08 |
| K962320 | S3 CARDIOPLEGIA CONTROL | Stoeckert Instrumente | 1997-01-10 |
| K953838 | MYOCARDIAL PROTECTION SYSTEM | Quest Medical, Inc. | 1996-03-06 |
| K944219 | SINGLE PASS BLOOD CARDIOPLEGIA SPBC SYSTEM COMPONENTS | Gish Biomedical, Inc. | 1995-06-30 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08054117372545 | HORIZON | EUROSETS SRL | 2026-05-05 |
| 08054117372446 | TRILLY | EUROSETS SRL | 2026-05-05 |
| 18051160302212 | Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W | SPECTRUM MEDICAL SRL | 2026-03-18 |
| 08033178114486 | Vanguard | SORIN GROUP ITALIA SRL | 2025-10-31 |
| 08033178114288 | Vanguard | SORIN GROUP ITALIA SRL | 2025-10-31 |
| 08033178114479 | Vanguard | SORIN GROUP ITALIA SRL | 2025-10-31 |
| 08033178112840 | KIDS | SORIN GROUP ITALIA SRL | 2024-03-20 |
| 08033178112864 | KIDS | SORIN GROUP ITALIA SRL | 2024-03-20 |
| 08033178113465 | KIDS | SORIN GROUP ITALIA SRL | 2024-03-20 |
| 08033178113472 | KIDS | SORIN GROUP ITALIA SRL | 2024-03-20 |
| 18051160302175 | Quantum PureFlow Standard Heat Exchanger High Flow 3/8 M | SPECTRUM MEDICAL SRL | 2023-05-04 |
| 08033178113366 | INSPIRE | SORIN GROUP ITALIA SRL | 2021-04-13 |
| 08033178113359 | INSPIRE | SORIN GROUP ITALIA SRL | 2021-04-13 |
| 08033178113342 | INSPIRE | SORIN GROUP ITALIA SRL | 2021-04-13 |
| 00634624500112 | MPS | QUEST MEDICAL INC | 2020-11-16 |
| 00634624500365 | MPS 3 Delivery Set w/AA w/183 Line (16C) | QUEST MEDICAL INC | 2020-07-27 |
| 00634624500310 | MPS 3 Delivery Set w/183cm (10C) | QUEST MEDICAL INC | 2020-07-27 |
| 00634624500327 | MPS 3 Delivery Set w/AA w/183 Line (10C) | QUEST MEDICAL INC | 2020-07-27 |
| 00634624500334 | MPS 3 Delivery Set w/AA w/106cm (10C) | QUEST MEDICAL INC | 2020-07-27 |
| 00634624500341 | MPS 3 Delivery Set w/AA w/106cm (16C) | QUEST MEDICAL INC | 2020-07-27 |
| 00634624500358 | MPS 3 Delivery Set w/183cm (16C) | QUEST MEDICAL INC | 2020-07-27 |
| 20634624524167 | MPS Power Cord, North America | QUEST MEDICAL INC | 2019-10-10 |
| 20634624524174 | MPS Power Cord, North America, Refurbished | QUEST MEDICAL INC | 2019-10-10 |
| B0664110090000 | GOODWIN HEART LINE | NOVOSCI CORP. | 2019-02-05 |
| 00634624501102 | MPS Delivery Set | QUEST MEDICAL INC | 2016-06-08 |
| B0664110080000 | EXTENSION LINE W/16 GA MODIFIED NEEDLE | NOVOSCI CORP. | 2015-10-09 |
| 00634624501126 | MPS | QUEST MEDICAL INC | 2015-09-16 |
| 08033178109062 | CSC 14 | SORIN GROUP ITALIA SRL | 2015-07-10 |
| 00613994947789 | CB MYOTherm XP® | MEDTRONIC, INC. | 2015-06-19 |
| 00613994947796 | CB MYOtherm XP® | MEDTRONIC, INC. | 2015-06-09 |