FDA 510(k) Applications for Medical Device Product Code "DTR"
(Heat-Exchanger, Cardiopulmonary Bypass)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K900640 | 3M COMPANY | MODIFIED MP-4 CARDIOPLEGIA DELIVERY SYSTEM W/CONDU | 04/20/1990 |
| K897039 | 3M COMPANY | SARNS MINIPRIME CARDIOPLEGIA SET W/CONDUCER(TM) | 03/16/1990 |
| K800377 | 3M HEALTH CARE, SARNS | CARDIOPLEGIA DELIVERY SYSTEM | 03/19/1980 |
| K823451 | 3M HEALTH CARE, SARNS | CLEAR CARDIOPLEJIA DELIVERY SYSTEM | 01/14/1983 |
| K923311 | 3M HEALTH CARE, SARNS | CONDUCER HEAT EXCHANGER | 09/18/1992 |
| K832417 | 3M HEALTH CARE, SARNS | HYPOTHERMIC MYCARDIAL PROTECTION DEV | 10/20/1983 |
| K883071 | 3M HEALTH CARE, SARNS | SARNS MP4 CARDIOPLEGIA DELIVERY SYSTEM | 12/05/1988 |
| K853516 | 3M HEALTH CARE, SARNS | SARNS RETROGRADE CARDIOPLEGIA DELIVERY SYSTEM | 11/14/1985 |
| K831157 | AMERICAN BENTLEY | BLOOD CARDIOPLEGIA STAINLESS STEEL COOL | 05/09/1983 |
| K840045 | AMERICAN BENTLEY | CARDIOPLEGIA HEAT EXCHANGER HE-100 | 02/13/1984 |
| K840256 | AMERICAN BENTLEY | CARDIOPLEGIA HEAT EXCHANGER HOLDER | 02/17/1984 |
| K870804 | AMERICAN BENTLEY | CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-100 | 09/01/1987 |
| K802848 | BENTLEY LABORATORIES, INC. | CARDIOPLEGIA COOLING SYST. CCAS-2 | 12/11/1980 |
| K931967 | BENTLEY LABORATORIES, INC. | HE-30 GOLD | 07/13/1993 |
| K860523 | BIO-VASCULAR, INC. | CARDIO-COOL | 04/29/1986 |
| K032068 | CARDIOVENTION, INC. | CARDIOVENTION CORX IOS-200 SYSTEM, MODEL IOS-200 | 08/22/2003 |
| K944267 | COBE CARDIOVASCULAR, INC. | HEAT EXCHANGER MODIFICATION FOR DUO AND OPTIMA | 04/28/1995 |
| 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 |
| K812093 | COBE LABORATORIES, INC. | COBE HEAT EXCHANGER RESERVOIR MODULE | 08/13/1981 |
| K781764 | COBE LABORATORIES, INC. | PAD, COOLING #27-999 | 12/04/1978 |
| K800717 | COBE LABORATORIES, INC. | TOPICAL COOLING DEV. TCD. #27-999 | 04/16/1980 |
| K905568 | DAILY MEDICAL PRODUCTS, INC. | TOPICAL COOLING PAD, MODEL 7000 | 01/23/1991 |
| K790756 | DELTA MEDICAL INDUSTRIES | HEAT EXCHANGER COIL | 06/11/1979 |
| K781210 | DELTA MEDICAL INDUSTRIES | HEAT EXCHANGER, FHX-14 | 10/10/1978 |
| K913077 | DLP, INC. | LANCASTER COOLING JACKET, CAT. CODE #13500/13501 | 01/09/1992 |
| K770016 | ELECTRO-CATHETER CORP. | PACING KIT, ELECATH TRANSTHORACIC | 01/14/1977 |
| K770018 | ELECTRO-CATHETER CORP. | PACING KIT, SEMI-FLOATING | 01/14/1977 |
| K770017 | ELECTRO-CATHETER CORP. | PACING KIT, TRANSMYOCARDIAL | 01/14/1977 |
| K813264 | ELECTROMEDICS, INC. | D6ZO DISPOSABLE HEAT EXCHANGER | 07/06/1982 |
| K934355 | ELECTROMEDICS, INC. | ELECTROMEDICS BLOOD HEAT EXCHANGER | 12/03/1993 |
| K873561 | ELECTROMEDICS, INC. | ELECTROMEDICS D1079E | 11/05/1987 |
| K833662 | GISH BIOMEDICAL, INC. | CARDIOPLEGIA SYSTEM CCS-XXX SERIES | 12/29/1983 |
| K871774 | GISH BIOMEDICAL, INC. | CCS-XXX, CARDIOPLEGIA ADMINISTRATION SETS | 08/03/1987 |
| K861102 | GISH BIOMEDICAL, INC. | CPS-3000 CARDIOPLEGIA RESERVOIR | 05/28/1986 |
| K913691 | GISH BIOMEDICAL, INC. | CPS-PLUS CARDIOPLEGIA SYSTEMS, CAT# CPS-X SERIES | 12/18/1991 |
| K896020 | GISH BIOMEDICAL, INC. | EXTRACORPOREAL HEAT EXCHANGER "HE SERIES" | 05/17/1990 |
| K081838 | GISH BIOMEDICAL, INC. | GISH VISION BLOOD CARDIOPLEGIA WITH HA COATING | 01/26/2009 |
| K944219 | GISH BIOMEDICAL, INC. | SINGLE PASS BLOOD CARDIOPLEGIA SPBC SYSTEM COMPONENTS | 06/30/1995 |
| K896807 | GISH BIOMEDICAL, INC. | SPBC SERIES SINGLE PASS BLOOD CARDIOPLEGIA SYSTEM | 07/31/1990 |
| 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 |
| K850794 | HONEYWELL, INC. | PATIENT MONITOR MODEL RM-300 | 04/18/1985 |
| K853410 | INTERMEDICS, INC. | MODEL 492-03 POLYFLEX IMPLANTABLE PACING LEAD | 10/11/1985 |
| 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 |
| K883439 | MEDTRONIC BLOOD SYSTEMS, INC. | INTERSEPT*CRYSTALLOID CARDIOPLEGIA DELIVERY SYSTEM | 10/13/1988 |
| 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 |
| K914742 | MEDTRONIC VASCULAR | MYOCARD PROTECT SYST W/BLOOD CARDIO HEAT EXC/MODIF | 12/04/1991 |
| K905500 | MEDTRONIC VASCULAR | MYOCARDIAL PROTECTION SYSTEM | 06/10/1991 |
| 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 |
| K932251 | MERIT MEDICAL SYSTEMS, INC. | ROTATOR;MALE-MALE, MALE-FEMALE | 08/05/1993 |
| K991137 | MINNTECH CORP. | ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER | 06/08/2000 |
| K853791 | NORTON PERFORMANCE PLASTICS CORP. | NORTON CARDIOPLEGIC QUICK COOLING COIL 421738-000 | 12/09/1985 |
| K843983 | NORTON TEXAS MEDICAL PRODUCTS | MYOCARDIAL INSULATOR | 12/27/1984 |
| K000977 | OLSON MEDICAL SALES, INC. | COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT - HEAT EXCHANGER COILS | 03/23/2001 |
| 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 |
| K904171 | SCIMED | SCIMED CARDIOTHERM CARDIOPLEGIA DELIVERY SYSTEM | 12/06/1990 |
| K772117 | SCIMED LIFE SYSTEMS, INC. | HEAT EXCHANGER, DISP., OMNITHERM | 03/02/1978 |
| K884560 | SCIMED LIFE SYSTEMS, INC. | SCIMED ECMOTHERM(TM) HEAT EXCHANGER | 04/03/1989 |
| K880451 | SCIMED LIFE SYSTEMS, INC. | SCIMED MODELS P-7-14 AND A-19-38 HEAT EXCHANGERS | 04/28/1988 |
| K883331 | SHILEY, INC. | BASIC HEATER-COOLER UNIT W/MAST, 115/110V 16-21-10 | 09/26/1988 |
| K883330 | SHILEY, INC. | BASIC HEATER-COOLER UNIT, 115/100V 16-02-20 | 09/26/1988 |
| K910923 | SHILEY, INC. | BCD ADVANCED | 04/09/1991 |
| K852780 | SHILEY, INC. | BCD PLUS BLOOD CARDIOPLEGIA SYS(HEREAF REFER DEV) | 09/30/1985 |
| K811204 | SHILEY, INC. | BRONCHEK-SHILEY CARDIAC JACKET & BSC J | 05/21/1981 |
| K802879 | SHILEY, INC. | BUCKBERG-SHILEY BLOOD CARDIOPLEGIC SPL. | 12/19/1980 |
| K823533 | SHILEY, INC. | JACKET & SET | 12/30/1982 |
| K833555 | SHILEY, INC. | LAL TEST RELEASE & BONCHEK CAR/JACKET | 02/04/1984 |
| K883332 | SHILEY, INC. | MAST FOR BASIC HEATER-COOLER UNIT 16-09-00 | 09/26/1988 |
| K880663 | SHILEY, INC. | SHILEY BCD PLUS HEAT EXCHANGER | 05/11/1988 |
| K860920 | SHILEY, INC. | STOCKERT-SHILEY HEATER/COOLER TEMPERATURE CONTROL | 05/21/1986 |
| K925369 | SORIN BIOMEDICA, FIAT, USA, INC. | BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMS | 03/26/1993 |
| K962320 | STOECKERT INSTRUMENTE | S3 CARDIOPLEGIA CONTROL | 01/10/1997 |
| K982467 | TERUMO MEDICAL CORP. | CAPIOX CARDIOPLEGIA | 06/23/1999 |
| K802545 | TEXAS MEDICAL PRODUCTS, INC. | CARDIOPLEGIC SETS | 01/16/1981 |
| K791430 | TRAVENOL LABORATORIES, S.A. | MINIPRIME HYPOTHERMIC HEAT EXCHANGER | 08/28/1979 |
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