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 |
K200438 |
Quest Medical, Inc. |
MPS 3 Myocardial Protection System |
06/19/2020 |
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 |
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 |