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
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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