DYG

THERMAL DILUTION CATHETER

Advisory panel: Cardiovascular
Total cleared: 99

Adverse events under product code DYG

product code DYG

Death: 18
Malfunction: 1,051
Other: 1
Total: 1,070

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code DYG

K242451 — HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100) Edwards Lifesciences · 2024-12-09
K233983 — Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100) Edwards Lifesciences · 2024-06-27
K233824 — Swan-Ganz catheter Edwards Lifesciences, LLC · 2024-06-06
K231248 — Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform Edwards Lifesciencess, LLC · 2023-09-21
K222117 — Swang-Ganz IQ pulmonary artery catheter Edwards Lifesiences, LLC · 2022-12-09
K193466 — Swan-Ganz Catheters Edwards Lifesciences, LLC · 2020-02-16
K160084 — Swan Ganz Catheters Edwards Lifesciences, LLC · 2016-05-03
K094048 — PERCUPRO MESSENGER BALLOON CATHETER Cardiosolutions, Inc. · 2011-07-14
K081052 — OCCLUSION BALLOON CATHETER, MODEL VENOS Oscor, Inc. · 2008-06-18
K010253 — ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101 Transonic Systems, Inc. · 2002-03-19
K012225 — ATTAIN 6215 VENOGRAM BALLOON CATHETER Medtronic Vascular · 2001-08-28
K003118 — Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0 Zcv ,Inc. · 2000-12-20
K001063 — SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7 Baxter Healthcare Corp · 2000-07-07
K993245 — CONTINOUS CARDIAC OUTPUT PULMONARY ARTERY CATHETER, MODEL TRUCATH, CONTINOUS CARDIAC OUTPUT MONITOR, MODEL TRUCCOM Alba Critical Care, Ltd. · 1999-10-28
K963336 — HARMAC THERMODILUTION CATHETER Harmac Medical Products, Inc. · 1997-08-14
K955816 — VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY (CCO/SVO2) MONITOR Baxter Healthcare Corp · 1997-05-06
K963248 — FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575-110P) J-Lloyd Medical, Inc. · 1997-02-03
K961999 — SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS Boston Scientific Scimed, Inc. · 1996-11-19
K951566 — SWAN-GANZE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS INFUSION PORT/EJECTION FRACTION/VOLUMETRIC (CCO/SVO2/VIP/REF) CATH] Baxter Healthcare Corp · 1995-11-27
K940547 — FLOW DIRECT THERMODILUT BALLOON CATH HEPARIN COATED J-Lloyd Medical, Inc. · 1994-08-11
K940795 — SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETER Baxter Edwards · 1994-05-24
K935404 — FLOW DIRECTED THERMODILUTION BALLOON CATHETER J-Lloyd Medical, Inc. · 1994-05-03
K934742 — SWAN-GANZ CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS PORT Baxter Healthcare Corp · 1994-01-24
K924452 — SWAN-GANZ CCO/SVO2 THERMODILUTION CATHETER Baxter Healthcare Corp · 1993-10-29
K925444 — CARDIAC OUTPUT PULMONARY ARTERY CATHETER & MONITOR Ami-Med Corp. · 1993-07-19
K920869 — FLOW DIRECTED THERMODILUTION BALLOON CATHETER J-Lloyd Medical, Inc. · 1993-01-13
K911840 — INTERFLO MEDICAL MODEL PA3-H CCO/PAC CATHETER Intec Medical, Inc. · 1991-06-03
K901287 — INTHERM TEMPORARY OCCLUSION CATHETER Interventional Therapeutics Corp. · 1991-02-20
K904287 — STEALTH DILATION CATHETER SYSTEM/MODIFICATION Target Therapeutics · 1991-01-16
K901247 — TRI ADAPTER W/ADJUSTABLE HEMOSTASIS VALVES Intec Medical, Inc. · 1990-07-31
K900879 — SOFT-WEDGE(TM) SYRINGE Baxter Healthcare Corp · 1990-05-10
K896466 — SWAN-GANZ THERMODILUTION EJECTION FRACTION/VOLUME Baxter Healthcare Corp · 1990-02-08
K892530 — CATHETERS FOR BALLOON OCCLUSION FEMORAL ANGIOGRAPH Arrow Intl., Inc. · 1989-09-26
K893435 — SILICONE FLOW-DIRECTED THERMODILUTION CATHETER Cathlab Corp. · 1989-09-26
K893474 — BARD CATH LAB THERMODILUTION CATHETER C.R. Bard, Inc. · 1989-09-05
K883948 — MODIFIED NUMED BALLOON ANGIOGRAPHIC CATHETER NuMED, Inc. · 1989-04-21
K874465 — SORENSON THERMO. FLOW-DIRECT TRANS PACE CATH/LEAD Abbott Laboratories · 1988-05-25
K874117 — MEDTRONIC MODEL 6550 ADJUSTABLE HEMOSTASIS VALVE Medtronic Vascular · 1987-11-05
K872770 — DUAL-THERMISTOR THERMODILUTION CATH. & INFU. CATH. Nova Medical Specialties · 1987-10-15
K862119 — DESERET FLO-THRU INJECTATE TEMPERATURE SENSOR Parke-Davis Co. · 1986-08-29
K853383 — CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SIN Webster Laboratories, Inc. · 1985-12-03
K852294 — BARD-PARKER OCCLUSION BALLOON CATHETER Bd Becton Dickinson Vacutainer Systems Preanalytic · 1985-09-17
K850952 — BARD CRITICAL CARE THERMODILUTIN CATHETER W/INFUSI C.R. Bard, Inc. · 1985-08-05
K851948 — MEDTRONIC MODEL 6404 Medtronic Vascular · 1985-06-20
K843409 — FLOW-DIRECTED THERMODILUTION CATH Andover Medical, Inc. · 1984-10-18
K843411 — THERMAL DILUTION CATHETER Andover Medical, Inc. · 1984-10-18
K841639 — NOVA BALLOON THERMODILUTION CATH. Nova Medical Specialties · 1984-08-12
K841640 — NOVA BALLOON THERMODILUTION INFUSION Nova Medical Specialties · 1984-08-12
K841705 — WEDGE PRESSURE CATHETER FLOW DIRECTED Mansfield Scientific, Inc. · 1984-07-13
K841876 — POLYURETHANE THERMAL DILUTION CATHET Waters Instruments, Inc. · 1984-07-13
K841251 — DESERET HEPARIN COATED FLOW CATH Parke-Davis Co. · 1984-06-11
K841317 — DESERET HEPARIN COATED FLOW DIRECTED Parke-Davis Co. · 1984-06-11
K833836 — IL HEPARINIZED FLOW DIRECTED THERMAL Instrumentation Laboratory CO · 1984-02-04
K833572 — HEPARIN-COATED BALLOON THERMODILUT Critikon Company, LLC · 1984-01-30
K833918 — INFUSION PORT BALLOON THERMODILUTION Critikon Company, LLC · 1984-01-30
K834036 — HEPARIN COATED BALLOON THERMODILU Nova Medical Specialties · 1984-01-10
K834037 — HEPARIN COATED BALLOON THERMODILU Nova Medical Specialties · 1984-01-10
K832380 — PROTECTIVE SLEEVE Vertex Medical Corp. · 1983-11-28
K832324 — THERMAL DILUTION CATHETER Catheter Corp. of America · 1983-11-03
K831854 — USCI ANGIOGRAPHIC BALLOON CATHETER C.R. Bard, Inc. · 1983-10-20
K832287 — NOVA BALLOON THERMODILUTION INFUSION Nova Medical Specialties · 1983-10-19
K832957 — FLOW-DIRECTED HEPARIN COATED THERMODIL Sorensen Research · 1983-09-29
K831945 — ELECATH BALTHERM TLC THERMAL DILUTION Electro-Catheter Corp. · 1983-08-12
K830604 — WEDGE PRESSURE CATHETER Plasmedics, Inc. · 1983-07-18
K831185 — CARDIAC OUTPUT MEASURE SYSTEM Cook, Inc. · 1983-05-27
K823484 — THERMAL DILUTION CATHETER Instrumentation Laboratory CO · 1982-12-22
K823433 — BALLOON THERMODILUTION CATHETER #7164& Critikon Company, LLC · 1982-11-30
K822806 — BALLOON WEDGE PRESSURE, ANGIOGRAPHIC Nova Medical Specialties · 1982-11-01
K823007 — OPTICATH HEPARIN COATED, FLOW-DIRECT Oximetrix, Inc. · 1982-11-01
K822723 — SWAN-GANZ BIPOLAR PACING CATHETER American Edwards Laboratories · 1982-10-15
K822034 — BALLOON WEDGE PRESSURE CATHETER Ziehm International, Inc. · 1982-08-24
K822350 — SWAN-GANZ FLOW-DIRECTED THERMODIL. CATH American Edwards Laboratories · 1982-08-24
K821996 — LEONARD PERIPHERAL VENOUS PRESSURE CATH Norton Performance Plastics Corp. · 1982-07-30
K821004 — MEDTRONIC S3 TM SYSTEM Medtronic Vascular · 1982-05-25
K821057 — FLOW DIRECTED THERMAL-DILUTION INFUSION Oximetrix, Inc. · 1982-05-18
K821099 — HEPARIN COATED THERMODILUTION CATHETER Kma, Inc. · 1982-05-18
K821235 — HEPARIN COATED THERMODILUTION CATHETER Gould, Inc. · 1982-05-18
K820883 — SEPTISLEEVE Argon Medical Corp. · 1982-04-29
K820702 — IL 7F FLOW DIRECTOR THERMAL DILU. CATH Instrumentation Laboratory CO · 1982-04-21
K820222 — SWAN-GANZ VIP-CATHETER American Edwards Laboratories · 1982-02-12
K820229 — NORTON FLOW DIRECTED THERMODILUTION CATH Norton Performance Plastics Corp. · 1982-02-12
K813578 — HEMOSTATIC SIDE-ARM ADAPTER Advanced Catheter Systems · 1982-01-18
K812111 — PRUITT ARTERIAL OCCLUSION CHOLANG. CATH Bionomy, Inc. · 1981-11-16
K812324 — FLOW-DIRECTED THERMODILUTION CATHETER Sorensen Research · 1981-09-25
K812563 — SWAN-GANZ & EDSLAB HEPARIN COATED CATH. American Edwards Laboratories · 1981-09-25
K811276 — OCCLUSION CATHETER Bionomy, Inc. · 1981-06-30
K810352 — SWAN-GANZ FLOW-DIRECTED THERMODILUTION American Edwards Laboratories · 1981-03-27
K810124 — SWAN-GANZ VIP THERMODILUTION CATHETER American Edwards Laboratories · 1981-02-04
K802288 — SWAN GANZ CATHETER PLACEMENT KIT Stanco Medical, Inc. · 1980-11-20
K802481 — 7FRENCH FLOW DIRECTED TRIPLE LUMEN CATH Waters Assoc., Inc. · 1980-10-31
K802338 — TORQUE CONTROL BALLOON CATHETER Cordis Corp. · 1980-10-10
K801865 — CORDIS FLOW DIRECTED BALLOON CATHETER Cordis Corp. · 1980-08-20
K782071 — CATHETER, USCI GRUNTZIG/BALLOON C.R. Bard, Inc. · 1978-12-15
K771043 — SWAN GANZ Clincal Instruments Corp. · 1977-12-20
K771823 — CATHETER, CARDIOVASCULAR Usci, Div. C.R. Bard, Inc. · 1977-12-20
K772059 — CATHETER, PACING/MONITORING Electro-Catheter Corp. · 1977-11-15
K771306 — THERMOCATH Victory Engineering Corp. · 1977-09-14
K770522 — CATHETER, GRUNTZIG, BALLON Cook, Inc. · 1977-03-30
K760533 — CATHETER, FLOW DIRECTED THERMAL DILUTION Gould, Inc. · 1976-09-09

Data sourced from openFDA. This site is unofficial and independent of the FDA.