FDA 510(k) Applications for Medical Device Product Code "DTR"
(Heat-Exchanger, Cardiopulmonary Bypass)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K032068 | CARDIOVENTION, INC. | CARDIOVENTION CORX IOS-200 SYSTEM, MODEL IOS-200 | 08/22/2003 |
| K012898 | COBE CARDIOVASCULAR, INC. | MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM | 09/17/2001 |
| K021830 | COBE CARDIOVASCULAR, INC. | SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM | 07/02/2002 |
| K081838 | GISH BIOMEDICAL, INC. | GISH VISION BLOOD CARDIOPLEGIA WITH HA COATING | 01/26/2009 |
| K040355 | GISH BIOMEDICAL, INC. | VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPORAL HEAT EXCHANGER WITH GBS COATING | 03/15/2004 |
| K020106 | GISH BIOMEDICAL, INC. | VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPOREAL HEAT EXCHANGER | 04/10/2002 |
| K964571 | LIFESTREAM INT'L, INC. | VISION CARDIOPLEGIA DELIVERY SYSTEM | 08/08/1997 |
| K090555 | MAQUET CARDIOPULMONARY AG | PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, MODEL BIO-CHX 30 | 12/23/2009 |
| K072583 | MAQUET CARDIOPULMONARY AG | PLEGIOX CARDIOPLEGIA HEAT EXCHANGER, WITH SAFELINE COATING, MODEL(S) CHX30, BSQ-CHX 30 | 04/04/2008 |
| K973475 | MEDTRONIC VASCULAR | CARMEDA COATED CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS (CBCTXXX SERIES AND CBCTXXXBR SERIES) | 11/20/1997 |
| K003724 | MEDTRONIC VASCULAR | CBMYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM WITH CARMEDA BIOACTIVE SURFACE, MODELS CB41 AND CB41-B | 12/21/2000 |
| K162774 | Medtronic, Inc. | MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface (Bridge System) | 02/10/2017 |
| K162958 | Medtronic, Inc. | 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 | 02/01/2017 |
| K991137 | MINNTECH CORP. | ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER | 06/08/2000 |
| K000977 | OLSON MEDICAL SALES, INC. | COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT - HEAT EXCHANGER COILS | 03/23/2001 |
| K223879 | Quara S.r.l. | Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M) | 04/13/2023 |
| K200438 | Quest Medical, Inc. | MPS 3 Myocardial Protection System | 06/19/2020 |
| K201984 | Quest Medical, Inc. | MPS 3 ND Myocardial Protection System | 11/20/2020 |
| K041979 | QUEST MEDICAL, INC. | MPS MYOCARDIAL PROTECTION SYSTEM - MPS 2 CONSOLE, MODEL 5201260 | 09/02/2004 |
| K173716 | Quest Medical, Inc. | MPS2 Myocardial Protection System Console | 10/01/2018 |
| K953838 | QUEST MEDICAL, INC. | MYOCARDIAL PROTECTION SYSTEM | 03/06/1996 |
| K220110 | Qura S.r.l. | Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger | 05/06/2022 |
| K212688 | Qura S.r.l. | Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger | 01/10/2022 |
| K962320 | STOECKERT INSTRUMENTE | S3 CARDIOPLEGIA CONTROL | 01/10/1997 |
| K982467 | TERUMO MEDICAL CORP. | CAPIOX CARDIOPLEGIA | 06/23/1999 |
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