FDA 510(k) Applications for Medical Device Product Code "DYG"
(Catheter, Flow Directed)

FDA 510(k) Number Applicant Device Name Decision Date
K874465 ABBOTT LABORATORIES SORENSON THERMO. FLOW-DIRECT TRANS PACE CATH/LEAD 05/25/1988
K813578 ADVANCED CATHETER SYSTEMS HEMOSTATIC SIDE-ARM ADAPTER 01/18/1982
K993245 ALBA CRITICAL CARE LTD CONTINOUS CARDIAC OUTPUT PULMONARY ARTERY CATHETER, MODEL TRUCATH, CONTINOUS CARDIAC OUTPUT MONITOR, MODEL TRUCCOM 10/28/1999
K812563 AMERICAN EDWARDS LABORATORIES SWAN-GANZ & EDSLAB HEPARIN COATED CATH. 09/25/1981
K822723 AMERICAN EDWARDS LABORATORIES SWAN-GANZ BIPOLAR PACING CATHETER 10/15/1982
K822350 AMERICAN EDWARDS LABORATORIES SWAN-GANZ FLOW-DIRECTED THERMODIL. CATH 08/24/1982
K810352 AMERICAN EDWARDS LABORATORIES SWAN-GANZ FLOW-DIRECTED THERMODILUTION 03/27/1981
K810124 AMERICAN EDWARDS LABORATORIES SWAN-GANZ VIP THERMODILUTION CATHETER 02/04/1981
K820222 AMERICAN EDWARDS LABORATORIES SWAN-GANZ VIP-CATHETER 02/12/1982
K925444 AMI-MED CORP. CARDIAC OUTPUT PULMONARY ARTERY CATHETER & MONITOR 07/19/1993
K843409 ANDOVER MEDICAL, INC. FLOW-DIRECTED THERMODILUTION CATH 10/18/1984
K843411 ANDOVER MEDICAL, INC. THERMAL DILUTION CATHETER 10/18/1984
K820883 ARGON MEDICAL CORP. SEPTISLEEVE 04/29/1982
K892530 ARROW INTL., INC. CATHETERS FOR BALLOON OCCLUSION FEMORAL ANGIOGRAPH 09/26/1989
K940795 BAXTER EDWARDS SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETER 05/24/1994
K900879 BAXTER HEALTHCARE CORP. SOFT-WEDGE(TM) SYRINGE 05/10/1990
K924452 BAXTER HEALTHCARE CORP. SWAN-GANZ CCO/SVO2 THERMODILUTION CATHETER 10/29/1993
K934742 BAXTER HEALTHCARE CORP. SWAN-GANZ CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS PORT 01/24/1994
K001063 BAXTER HEALTHCARE CORP. SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7 07/07/2000
K896466 BAXTER HEALTHCARE CORP. SWAN-GANZ THERMODILUTION EJECTION FRACTION/VOLUME 02/08/1990
K951566 BAXTER HEALTHCARE CORP. SWAN-GANZE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS INFUSION PORT/EJECTION FRACTION/VOLUMETRIC (CCO/SVO2/VIP/REF) CATH] 11/27/1995
K955816 BAXTER HEALTHCARE CORP. VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY (CCO/SVO2) MONITOR 05/06/1997
K852294 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC BARD-PARKER OCCLUSION BALLOON CATHETER 09/17/1985
K811276 BIONOMY, INC. OCCLUSION CATHETER 06/30/1981
K812111 BIONOMY, INC. PRUITT ARTERIAL OCCLUSION CHOLANG. CATH 11/16/1981
K961999 BOSTON SCIENTIFIC SCIMED, INC. SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS 11/19/1996
K893474 C.R. BARD, INC. BARD CATH LAB THERMODILUTION CATHETER 09/05/1989
K850952 C.R. BARD, INC. BARD CRITICAL CARE THERMODILUTIN CATHETER W/INFUSI 08/05/1985
K782071 C.R. BARD, INC. CATHETER, USCI GRUNTZIG/BALLOON 12/15/1978
K831854 C.R. BARD, INC. USCI ANGIOGRAPHIC BALLOON CATHETER 10/20/1983
K094048 CARDIOSOLUTIONS INC PERCUPRO MESSENGER BALLOON CATHETER 07/14/2011
K832324 CATHETER CORP. OF AMERICA THERMAL DILUTION CATHETER 11/03/1983
K893435 CATHLAB CORP. SILICONE FLOW-DIRECTED THERMODILUTION CATHETER 09/26/1989
K771043 CLINCAL INSTRUMENTS CORP. SWAN GANZ 12/20/1977
K831185 COOK, INC. CARDIAC OUTPUT MEASURE SYSTEM 05/27/1983
K770522 COOK, INC. CATHETER, GRUNTZIG, BALLON 03/30/1977
K801865 CORDIS CORP. CORDIS FLOW DIRECTED BALLOON CATHETER 08/20/1980
K802338 CORDIS CORP. TORQUE CONTROL BALLOON CATHETER 10/10/1980
K823433 CRITIKON COMPANY,LLC BALLOON THERMODILUTION CATHETER #7164& 11/30/1982
K833572 CRITIKON COMPANY,LLC HEPARIN-COATED BALLOON THERMODILUT 01/30/1984
K833918 CRITIKON COMPANY,LLC INFUSION PORT BALLOON THERMODILUTION 01/30/1984
K160084 Edwards Lifesciences, LLC Swan Ganz Catheters 05/03/2016
K772059 ELECTRO-CATHETER CORP. CATHETER, PACING/MONITORING 11/15/1977
K831945 ELECTRO-CATHETER CORP. ELECATH BALTHERM TLC THERMAL DILUTION 08/12/1983
K760533 GOULD, INC. CATHETER, FLOW DIRECTED THERMAL DILUTION 09/09/1976
K821235 GOULD, INC. HEPARIN COATED THERMODILUTION CATHETER 05/18/1982
K963336 HARMAC MEDICAL PRODUCTS, INC. HARMAC THERMODILUTION CATHETER 08/14/1997
K820702 INSTRUMENTATION LABORATORY CO. IL 7F FLOW DIRECTOR THERMAL DILU. CATH 04/21/1982
K833836 INSTRUMENTATION LABORATORY CO. IL HEPARINIZED FLOW DIRECTED THERMAL 02/04/1984
K823484 INSTRUMENTATION LABORATORY CO. THERMAL DILUTION CATHETER 12/22/1982
K901247 INTEC MEDICAL, INC. "TRI" ADAPTER W/ADJUSTABLE HEMOSTASIS VALVES 07/31/1990
K911840 INTEC MEDICAL, INC. INTERFLO MEDICAL MODEL PA3-H CCO/PAC CATHETER 06/03/1991
K901287 INTERVENTIONAL THERAPEUTICS CORP. INTHERM TEMPORARY OCCLUSION CATHETER 02/20/1991
K940547 J-LLOYD MEDICAL, INC. FLOW DIRECT THERMODILUT BALLOON CATH HEPARIN COATED 08/11/1994
K920869 J-LLOYD MEDICAL, INC. FLOW DIRECTED THERMODILUTION BALLOON CATHETER 01/13/1993
K935404 J-LLOYD MEDICAL, INC. FLOW DIRECTED THERMODILUTION BALLOON CATHETER 05/03/1994
K963248 J-LLOYD MEDICAL, INC. FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575-110P) 02/03/1997
K821099 KMA, INC. HEPARIN COATED THERMODILUTION CATHETER 05/18/1982
K841705 MANSFIELD SCIENTIFIC, INC. WEDGE PRESSURE CATHETER FLOW DIRECTED 07/13/1984
K012225 MEDTRONIC VASCULAR ATTAIN 6215 VENOGRAM BALLOON CATHETER 08/28/2001
K851948 MEDTRONIC VASCULAR MEDTRONIC MODEL 6404 06/20/1985
K874117 MEDTRONIC VASCULAR MEDTRONIC MODEL 6550 ADJUSTABLE HEMOSTASIS VALVE 11/05/1987
K821004 MEDTRONIC VASCULAR MEDTRONIC S3 TM SYSTEM 05/25/1982
K821996 NORTON PERFORMANCE PLASTICS CORP. LEONARD PERIPHERAL VENOUS PRESSURE CATH 07/30/1982
K820229 NORTON PERFORMANCE PLASTICS CORP. NORTON FLOW DIRECTED THERMODILUTION CATH 02/12/1982
K822806 NOVA MEDICAL SPECIALTIES BALLOON WEDGE PRESSURE, ANGIOGRAPHIC 11/01/1982
K872770 NOVA MEDICAL SPECIALTIES DUAL-THERMISTOR THERMODILUTION CATH. & INFU. CATH. 10/15/1987
K834036 NOVA MEDICAL SPECIALTIES HEPARIN COATED BALLOON THERMODILU 01/10/1984
K834037 NOVA MEDICAL SPECIALTIES HEPARIN COATED BALLOON THERMODILU 01/10/1984
K841639 NOVA MEDICAL SPECIALTIES NOVA BALLOON THERMODILUTION CATH. 08/12/1984
K841640 NOVA MEDICAL SPECIALTIES NOVA BALLOON THERMODILUTION INFUSION 08/12/1984
K832287 NOVA MEDICAL SPECIALTIES NOVA BALLOON THERMODILUTION INFUSION 10/19/1983
K883948 NUMED, INC. MODIFIED NUMED BALLOON ANGIOGRAPHIC CATHETER 04/21/1989
K081052 Oscor Inc. OCCLUSION BALLOON CATHETER, MODEL VENOS 06/18/2008
K821057 OXIMETRIX, INC. FLOW DIRECTED THERMAL-DILUTION INFUSION 05/18/1982
K823007 OXIMETRIX, INC. OPTICATH HEPARIN COATED, FLOW-DIRECT 11/01/1982
K862119 PARKE-DAVIS CO. DESERET FLO-THRU INJECTATE TEMPERATURE SENSOR 08/29/1986
K841251 PARKE-DAVIS CO. DESERET HEPARIN COATED FLOW CATH 06/11/1984
K841317 PARKE-DAVIS CO. DESERET HEPARIN COATED FLOW DIRECTED 06/11/1984
K830604 PLASMEDICS, INC. WEDGE PRESSURE CATHETER 07/18/1983
K832957 SORENSEN RESEARCH FLOW-DIRECTED HEPARIN COATED THERMODIL 09/29/1983
K812324 SORENSEN RESEARCH FLOW-DIRECTED THERMODILUTION CATHETER 09/25/1981
K802288 STANCO MEDICAL, INC. SWAN GANZ CATHETER PLACEMENT KIT 11/20/1980
K904287 TARGET THERAPEUTICS STEALTH DILATION CATHETER SYSTEM/MODIFICATION 01/16/1991
K010253 TRANSONIC SYSTEMS, INC. ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101 03/19/2002
K771823 USCI, DIV. C.R. BARD, INC. CATHETER, CARDIOVASCULAR 12/20/1977
K832380 VERTEX MEDICAL CORP. PROTECTIVE SLEEVE 11/28/1983
K771306 VICTORY ENGINEERING CORP. THERMOCATH 09/14/1977
K802481 WATERS ASSOC., INC. 7FRENCH FLOW DIRECTED TRIPLE LUMEN CATH 10/31/1980
K841876 WATERS INSTRUMENTS, INC. POLYURETHANE THERMAL DILUTION CATHET 07/13/1984
K853383 WEBSTER LABORATORIES, INC. CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SIN 12/03/1985
K003118 ZCV ,INC. Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0 12/20/2000
K822034 ZIEHM INTERNATIONAL, INC. BALLOON WEDGE PRESSURE CATHETER 08/24/1982


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