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