FDA Product Code
FDA Product Code DYG — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1240
510(k) Clearances — 99 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| 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 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K233824 | Swan-Ganz catheter | Edwards Lifesciences, LLC | 2024-06-06 | Traditional | PDF ↗ |
| K231248 | Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform | Edwards Lifesciencess, LLC | 2023-09-21 | Traditional | PDF ↗ |
| K222117 | Swang-Ganz IQ pulmonary artery catheter | Edwards Lifesiences, LLC | 2022-12-09 | Traditional | PDF ↗ |
| K193466 | Swan-Ganz Catheters | Edwards Lifesciences, LLC | 2020-02-16 | Traditional | PDF ↗ |
| K160084 | Swan Ganz Catheters | Edwards Lifesciences, LLC | 2016-05-03 | Traditional | PDF ↗ |
| K094048 | PERCUPRO MESSENGER BALLOON CATHETER | Cardiosolutions, Inc. | 2011-07-14 | Traditional | PDF ↗ |
| K081052 | OCCLUSION BALLOON CATHETER, MODEL VENOS | Oscor, Inc. | 2008-06-18 | Traditional | PDF ↗ |
| K010253 | ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101 | Transonic Systems, Inc. | 2002-03-19 | Traditional | PDF ↗ |
| K012225 | ATTAIN 6215 VENOGRAM BALLOON CATHETER | Medtronic Vascular | 2001-08-28 | Traditional | PDF ↗ |
| K003118 | Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0 | Zcv ,Inc. | 2000-12-20 | Traditional | PDF ↗ |
| K001063 | SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7 | Baxter Healthcare Corp | 2000-07-07 | Traditional | PDF ↗ |
| K993245 | CONTINOUS CARDIAC OUTPUT PULMONARY ARTERY CATHETER, MODEL TRUCATH, CONTINOUS CARDIAC OUTPUT MONITOR, MODEL TRUCCOM | Alba Critical Care, Ltd. | 1999-10-28 | Special | PDF ↗ |
| K963336 | HARMAC THERMODILUTION CATHETER | Harmac Medical Products, Inc. | 1997-08-14 | Traditional | PDF ↗ |
| K955816 | VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY (CCO/SVO2) MONITOR | Baxter Healthcare Corp | 1997-05-06 | Traditional | PDF ↗ |
| K963248 | FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575-110P) | J-Lloyd Medical, Inc. | 1997-02-03 | Traditional | PDF ↗ |
| K961999 | SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS | Boston Scientific Scimed, Inc. | 1996-11-19 | Traditional | PDF ↗ |
| K951566 | SWAN-GANZE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS INFUSION PORT/EJECTION FRACTION/VOLUMETRIC (CCO/SVO2/VIP/REF) CATH] | Baxter Healthcare Corp | 1995-11-27 | Traditional | PDF ↗ |
| K940547 | FLOW DIRECT THERMODILUT BALLOON CATH HEPARIN COATED | J-Lloyd Medical, Inc. | 1994-08-11 | Traditional | PDF ↗ |
| K940795 | SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETER | Baxter Edwards | 1994-05-24 | Traditional | PDF ↗ |
| K935404 | FLOW DIRECTED THERMODILUTION BALLOON CATHETER | J-Lloyd Medical, Inc. | 1994-05-03 | Traditional | PDF ↗ |
| K934742 | SWAN-GANZ CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS PORT | Baxter Healthcare Corp | 1994-01-24 | Traditional | PDF ↗ |
| K924452 | SWAN-GANZ CCO/SVO2 THERMODILUTION CATHETER | Baxter Healthcare Corp | 1993-10-29 | Traditional | PDF ↗ |
| K925444 | CARDIAC OUTPUT PULMONARY ARTERY CATHETER & MONITOR | Ami-Med Corp. | 1993-07-19 | Traditional | PDF ↗ |
| K920869 | FLOW DIRECTED THERMODILUTION BALLOON CATHETER | J-Lloyd Medical, Inc. | 1993-01-13 | Traditional | PDF ↗ |
| K911840 | INTERFLO MEDICAL MODEL PA3-H CCO/PAC CATHETER | Intec Medical, Inc. | 1991-06-03 | Traditional | PDF ↗ |
| K901287 | INTHERM TEMPORARY OCCLUSION CATHETER | Interventional Therapeutics Corp. | 1991-02-20 | Traditional | PDF ↗ |
| K904287 | STEALTH DILATION CATHETER SYSTEM/MODIFICATION | Target Therapeutics | 1991-01-16 | Traditional | PDF ↗ |
| K901247 | TRI ADAPTER W/ADJUSTABLE HEMOSTASIS VALVES | Intec Medical, Inc. | 1990-07-31 | Traditional | PDF ↗ |
| K900879 | SOFT-WEDGE(TM) SYRINGE | Baxter Healthcare Corp | 1990-05-10 | Traditional | PDF ↗ |
| K896466 | SWAN-GANZ THERMODILUTION EJECTION FRACTION/VOLUME | Baxter Healthcare Corp | 1990-02-08 | Traditional | PDF ↗ |
| K892530 | CATHETERS FOR BALLOON OCCLUSION FEMORAL ANGIOGRAPH | Arrow Intl., Inc. | 1989-09-26 | Traditional | PDF ↗ |
| K893435 | SILICONE FLOW-DIRECTED THERMODILUTION CATHETER | Cathlab Corp. | 1989-09-26 | Traditional | PDF ↗ |
| K893474 | BARD CATH LAB THERMODILUTION CATHETER | C.R. Bard, Inc. | 1989-09-05 | Traditional | PDF ↗ |
| K883948 | MODIFIED NUMED BALLOON ANGIOGRAPHIC CATHETER | NuMED, Inc. | 1989-04-21 | Traditional | PDF ↗ |
| K874465 | SORENSON THERMO. FLOW-DIRECT TRANS PACE CATH/LEAD | Abbott Laboratories | 1988-05-25 | Traditional | PDF ↗ |
| K874117 | MEDTRONIC MODEL 6550 ADJUSTABLE HEMOSTASIS VALVE | Medtronic Vascular | 1987-11-05 | Traditional | PDF ↗ |
| K872770 | DUAL-THERMISTOR THERMODILUTION CATH. & INFU. CATH. | Nova Medical Specialties | 1987-10-15 | Traditional | PDF ↗ |
| K862119 | DESERET FLO-THRU INJECTATE TEMPERATURE SENSOR | Parke-Davis Co. | 1986-08-29 | Traditional | PDF ↗ |
| K853383 | CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SIN | Webster Laboratories, Inc. | 1985-12-03 | Traditional | PDF ↗ |
| K852294 | BARD-PARKER OCCLUSION BALLOON CATHETER | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-09-17 | Traditional | PDF ↗ |
| K850952 | BARD CRITICAL CARE THERMODILUTIN CATHETER W/INFUSI | C.R. Bard, Inc. | 1985-08-05 | Traditional | PDF ↗ |
| K851948 | MEDTRONIC MODEL 6404 | Medtronic Vascular | 1985-06-20 | Traditional | PDF ↗ |
| K843409 | FLOW-DIRECTED THERMODILUTION CATH | Andover Medical, Inc. | 1984-10-18 | Traditional | PDF ↗ |
| K843411 | THERMAL DILUTION CATHETER | Andover Medical, Inc. | 1984-10-18 | Traditional | PDF ↗ |
| K841640 | NOVA BALLOON THERMODILUTION INFUSION | Nova Medical Specialties | 1984-08-12 | Traditional | PDF ↗ |
| K841639 | NOVA BALLOON THERMODILUTION CATH. | Nova Medical Specialties | 1984-08-12 | Traditional | PDF ↗ |
| K841876 | POLYURETHANE THERMAL DILUTION CATHET | Waters Instruments, Inc. | 1984-07-13 | Traditional | PDF ↗ |
| K841705 | WEDGE PRESSURE CATHETER FLOW DIRECTED | Mansfield Scientific, Inc. | 1984-07-13 | Traditional | PDF ↗ |
| K841251 | DESERET HEPARIN COATED FLOW CATH | Parke-Davis Co. | 1984-06-11 | Traditional | PDF ↗ |
| K841317 | DESERET HEPARIN COATED FLOW DIRECTED | Parke-Davis Co. | 1984-06-11 | Traditional | PDF ↗ |
| K833836 | IL HEPARINIZED FLOW DIRECTED THERMAL | Instrumentation Laboratory CO | 1984-02-04 | Traditional | PDF ↗ |
| K833572 | HEPARIN-COATED BALLOON THERMODILUT | Critikon Company, LLC | 1984-01-30 | Traditional | PDF ↗ |
| K833918 | INFUSION PORT BALLOON THERMODILUTION | Critikon Company, LLC | 1984-01-30 | Traditional | PDF ↗ |
| K834036 | HEPARIN COATED BALLOON THERMODILU | Nova Medical Specialties | 1984-01-10 | Traditional | PDF ↗ |
| K834037 | HEPARIN COATED BALLOON THERMODILU | Nova Medical Specialties | 1984-01-10 | Traditional | PDF ↗ |
| K832380 | PROTECTIVE SLEEVE | Vertex Medical Corp. | 1983-11-28 | Traditional | PDF ↗ |
| K832324 | THERMAL DILUTION CATHETER | Catheter Corp. of America | 1983-11-03 | Traditional | PDF ↗ |
| K831854 | USCI ANGIOGRAPHIC BALLOON CATHETER | C.R. Bard, Inc. | 1983-10-20 | Traditional | PDF ↗ |
| K832287 | NOVA BALLOON THERMODILUTION INFUSION | Nova Medical Specialties | 1983-10-19 | Traditional | PDF ↗ |
| K832957 | FLOW-DIRECTED HEPARIN COATED THERMODIL | Sorensen Research | 1983-09-29 | Traditional | PDF ↗ |
| K831945 | ELECATH BALTHERM TLC THERMAL DILUTION | Electro-Catheter Corp. | 1983-08-12 | Traditional | PDF ↗ |
| K830604 | WEDGE PRESSURE CATHETER | Plasmedics, Inc. | 1983-07-18 | Traditional | PDF ↗ |
| K831185 | CARDIAC OUTPUT MEASURE SYSTEM | Cook, Inc. | 1983-05-27 | Traditional | PDF ↗ |
| K823484 | THERMAL DILUTION CATHETER | Instrumentation Laboratory CO | 1982-12-22 | Traditional | PDF ↗ |
| K823433 | BALLOON THERMODILUTION CATHETER #7164& | Critikon Company, LLC | 1982-11-30 | Traditional | PDF ↗ |
| K822806 | BALLOON WEDGE PRESSURE, ANGIOGRAPHIC | Nova Medical Specialties | 1982-11-01 | Traditional | PDF ↗ |
| K823007 | OPTICATH HEPARIN COATED, FLOW-DIRECT | Oximetrix, Inc. | 1982-11-01 | Traditional | PDF ↗ |
| K822723 | SWAN-GANZ BIPOLAR PACING CATHETER | American Edwards Laboratories | 1982-10-15 | Traditional | PDF ↗ |
| K822350 | SWAN-GANZ FLOW-DIRECTED THERMODIL. CATH | American Edwards Laboratories | 1982-08-24 | Traditional | PDF ↗ |
| K822034 | BALLOON WEDGE PRESSURE CATHETER | Ziehm International, Inc. | 1982-08-24 | Traditional | PDF ↗ |
| K821996 | LEONARD PERIPHERAL VENOUS PRESSURE CATH | Norton Performance Plastics Corp. | 1982-07-30 | Traditional | PDF ↗ |
| K821004 | MEDTRONIC S3 TM SYSTEM | Medtronic Vascular | 1982-05-25 | Traditional | PDF ↗ |
| K821235 | HEPARIN COATED THERMODILUTION CATHETER | Gould, Inc. | 1982-05-18 | Traditional | PDF ↗ |
| K821099 | HEPARIN COATED THERMODILUTION CATHETER | Kma, Inc. | 1982-05-18 | Traditional | PDF ↗ |
| K821057 | FLOW DIRECTED THERMAL-DILUTION INFUSION | Oximetrix, Inc. | 1982-05-18 | Traditional | PDF ↗ |
| K820883 | SEPTISLEEVE | Argon Medical Corp. | 1982-04-29 | Traditional | PDF ↗ |
| K820702 | IL 7F FLOW DIRECTOR THERMAL DILU. CATH | Instrumentation Laboratory CO | 1982-04-21 | Traditional | PDF ↗ |
| K820222 | SWAN-GANZ VIP-CATHETER | American Edwards Laboratories | 1982-02-12 | Traditional | PDF ↗ |
| K820229 | NORTON FLOW DIRECTED THERMODILUTION CATH | Norton Performance Plastics Corp. | 1982-02-12 | Traditional | PDF ↗ |
| K813578 | HEMOSTATIC SIDE-ARM ADAPTER | Advanced Catheter Systems | 1982-01-18 | Traditional | PDF ↗ |
| K812111 | PRUITT ARTERIAL OCCLUSION CHOLANG. CATH | Bionomy, Inc. | 1981-11-16 | Traditional | PDF ↗ |
| K812563 | SWAN-GANZ & EDSLAB HEPARIN COATED CATH. | American Edwards Laboratories | 1981-09-25 | Traditional | PDF ↗ |
| K812324 | FLOW-DIRECTED THERMODILUTION CATHETER | Sorensen Research | 1981-09-25 | Traditional | PDF ↗ |
| K811276 | OCCLUSION CATHETER | Bionomy, Inc. | 1981-06-30 | Traditional | PDF ↗ |
| K810352 | SWAN-GANZ FLOW-DIRECTED THERMODILUTION | American Edwards Laboratories | 1981-03-27 | Traditional | PDF ↗ |
| K810124 | SWAN-GANZ VIP THERMODILUTION CATHETER | American Edwards Laboratories | 1981-02-04 | Traditional | PDF ↗ |
| K802288 | SWAN GANZ CATHETER PLACEMENT KIT | Stanco Medical, Inc. | 1980-11-20 | Traditional | PDF ↗ |
| K802481 | 7FRENCH FLOW DIRECTED TRIPLE LUMEN CATH | Waters Assoc., Inc. | 1980-10-31 | Traditional | PDF ↗ |
| K802338 | TORQUE CONTROL BALLOON CATHETER | Cordis Corp. | 1980-10-10 | Traditional | PDF ↗ |
| K801865 | CORDIS FLOW DIRECTED BALLOON CATHETER | Cordis Corp. | 1980-08-20 | Traditional | PDF ↗ |
| K782071 | CATHETER, USCI GRUNTZIG/BALLOON | C.R. Bard, Inc. | 1978-12-15 | Traditional | PDF ↗ |
| K771043 | SWAN GANZ | Clincal Instruments Corp. | 1977-12-20 | Traditional | PDF ↗ |
| K771823 | CATHETER, CARDIOVASCULAR | Usci, Div. C.R. Bard, Inc. | 1977-12-20 | Traditional | PDF ↗ |
| K772059 | CATHETER, PACING/MONITORING | Electro-Catheter Corp. | 1977-11-15 | Traditional | PDF ↗ |
| K771306 | THERMOCATH | Victory Engineering Corp. | 1977-09-14 | Traditional | PDF ↗ |
| K770522 | CATHETER, GRUNTZIG, BALLON | Cook, Inc. | 1977-03-30 | Traditional | PDF ↗ |
| K760533 | CATHETER, FLOW DIRECTED THERMAL DILUTION | Gould, Inc. | 1976-09-09 | Traditional | PDF ↗ |
Product code DYG · Class II · Cardiovascular. Data: openFDA.