Catheter, Flow Directed
FDA product code DYG · Class II (moderate risk) · 21 CFR 870.1240 · Cardiovascular
99510(k) clearances
0PMA approvals
27recalls
Manufacturers
- Nova Medical Specialties 7
- Baxter Healthcare Corp 7
- American Edwards Laboratories 6
- Edwards Lifesciences, LLC 5
- J-Lloyd Medical, Inc. 4
- C.R. Bard, Inc. 4
- Medtronic Vascular 4
- Critikon Company, LLC 3
- Instrumentation Laboratory CO 3
- Parke-Davis Co. 3
- Sorensen Research 2
- Cook, Inc. 2
- Oximetrix, Inc. 2
- Intec Medical, Inc. 2
- Norton Performance Plastics Corp. 2
- Electro-Catheter Corp. 2
- Bionomy, Inc. 2
- Gould, Inc. 2
- Andover Medical, Inc. 2
- Cordis Corp. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242451 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…DYG · Traditional | Edwards Lifesciences | 12/09/2024SE |
| K233983 | Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5)…DYG · Traditional | Edwards Lifesciences | 06/27/2024SE |
| K233824 | Swan-Ganz catheterDYG · Traditional | Edwards Lifesciences, LLC | 06/06/2024SE |
| K231248 | Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…DYG · Traditional | Edwards Lifesciencess, LLC | 09/21/2023SE |
| K222117 | Swang-Ganz IQ pulmonary artery catheterDYG · Traditional | Edwards Lifesiences, LLC | 12/09/2022SE |
| K193466 | Swan-Ganz CathetersDYG · Traditional | Edwards Lifesciences, LLC | 02/16/2020SE |
| K160084 | Swan Ganz CathetersDYG · Traditional | Edwards Lifesciences, LLC | 05/03/2016SE |
| K094048 | Percupro Messenger Balloon CatheterDYG · Traditional | Cardiosolutions, Inc. | 07/14/2011SE |
| K081052 | Occlusion Balloon Catheter, Model VenosDYG · Traditional | Oscor, Inc. | 06/18/2008SE |
| K010253 | Angio Flow Thermodilution Catheter, Model AF-CATH-01; Angioflow Meter, Models HQ100 and…DYG · Traditional | Transonic Systems, Inc. | 03/19/2002SE |
| K012225 | Attain 6215 Venogram Balloon CatheterDYG · Traditional | Medtronic Vascular | 08/28/2001SE |
| K003118 | Z2 Balloon Guided Pacing & Pressure Monitoring Catheter, Model Z2-7-02-1-10-0DYG · Traditional | Zcv ,Inc. | 12/20/2000SE |
| K001063 | Swan-Ganz Synthetic Controlcath Thermodilution Catheters, Models C146F7, C146HF7…DYG · Traditional | Baxter Healthcare Corp | 07/07/2000SE |
| K993245 | Continous Cardiac Output Pulmonary Artery Catheter, Model Trucath, Continous Cardiac…DYG · Special | Alba Critical Care, Ltd. | 10/28/1999SE |
| K963336 | Harmac Thermodilution CatheterDYG · Traditional | Harmac Medical Products, Inc. | 08/14/1997SE |
| K955816 | Vigilance Continuous Cardiac Output/Oximetry (CCO/SVO2) MonitorDYG · Traditional | Baxter Healthcare Corp | 05/06/1997SE |
| K963248 | Flow Directed Thermodilution/Infusion Balloon Catheter (575-110P)DYG · Traditional | J-Lloyd Medical, Inc. | 02/03/1997SE |
| K961999 | Schneider Guider Softip Guiding CathetersDYG · Traditional | Boston Scientific Scimed, Inc. | 11/19/1996SE |
| K951566 | Swan-Ganze Continuous Cardiac Output/Oximetry/Venous Infusion Port/Ejection…DYG · Traditional | Baxter Healthcare Corp | 11/27/1995SE |
| K940547 | Flow Direct Thermodilut Balloon Cath Heparin CoatedDYG · Traditional | J-Lloyd Medical, Inc. | 08/11/1994SE |
| K940795 | Swan-Ganz CC0/SVO2 Thermodilution CatheterDYG · Traditional | Baxter Edwards | 05/24/1994SE |
| K935404 | Flow Directed Thermodilution Balloon CatheterDYG · Traditional | J-Lloyd Medical, Inc. | 05/03/1994SE |
| K934742 | Swan-Ganz Continuous Cardiac Output/Oximetry/Venous PortDYG · Traditional | Baxter Healthcare Corp | 01/24/1994SE |
| K924452 | Swan-Ganz CCO/SVO2 Thermodilution CatheterDYG · Traditional | Baxter Healthcare Corp | 10/29/1993SE |
| K925444 | Cardiac Output Pulmonary Artery Catheter & MonitorDYG · Traditional | Ami-Med Corp. | 07/19/1993SE |
| K920869 | Flow Directed Thermodilution Balloon CatheterDYG · Traditional | J-Lloyd Medical, Inc. | 01/13/1993SE |
| K911840 | Interflo Medical Model PA3-H Cco/Pac CatheterDYG · Traditional | Intec Medical, Inc. | 06/03/1991SE |
| K901287 | Intherm Temporary Occlusion CatheterDYG · Traditional | Interventional Therapeutics Corp. | 02/20/1991SE |
| K904287 | Stealth Dilation Catheter System/ModificationDYG · Traditional | Target Therapeutics | 01/16/1991SE |
| K901247 | Tri Adapter W/Adjustable Hemostasis ValvesDYG · Traditional | Intec Medical, Inc. | 07/31/1990SE |
| K900879 | Soft-Wedge(Tm) SyringeDYG · Traditional | Baxter Healthcare Corp | 05/10/1990SE |
| K896466 | Swan-Ganz Thermodilution Ejection Fraction/VolumeDYG · Traditional | Baxter Healthcare Corp | 02/08/1990SE |
| K893435 | Silicone Flow-Directed Thermodilution CatheterDYG · Traditional | Cathlab Corp. | 09/26/1989SE |
| K892530 | Catheters for Balloon Occlusion Femoral AngiographDYG · Traditional | Arrow Intl., Inc. | 09/26/1989SE |
| K893474 | Bard Cath Lab Thermodilution CatheterDYG · Traditional | C.R. Bard, Inc. | 09/05/1989SE |
| K883948 | Modified Numed Balloon Angiographic CatheterDYG · Traditional | NuMED, Inc. | 04/21/1989SE |
| K874465 | Sorenson Thermo. Flow-Direct Trans Pace Cath/LeadDYG · Traditional | Abbott Laboratories | 05/25/1988SE |
| K874117 | Medtronic Model 6550 Adjustable Hemostasis ValveDYG · Traditional | Medtronic Vascular | 11/05/1987SE |
| K872770 | Dual-Thermistor Thermodilution Cath. & Infu. Cath.DYG · Traditional | Nova Medical Specialties | 10/15/1987SE |
| K862119 | Deseret Flo-Thru Injectate Temperature SensorDYG · Traditional | Parke-Davis Co. | 08/29/1986SE |
| K853383 | Cardiovascular, Thermodilution, Flow, Coronary SinDYG · Traditional | Webster Laboratories, Inc. | 12/03/1985SE |
| K852294 | Bard-Parker Occlusion Balloon CatheterDYG · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 09/17/1985SE |
| K850952 | Bard Critical Care Thermodilutin Catheter W/InfusiDYG · Traditional | C.R. Bard, Inc. | 08/05/1985SE |
| K851948 | Medtronic Model 6404DYG · Traditional | Medtronic Vascular | 06/20/1985SE |
| K843411 | Thermal Dilution CatheterDYG · Traditional | Andover Medical, Inc. | 10/18/1984SE |
| K843409 | Flow-Directed Thermodilution CathDYG · Traditional | Andover Medical, Inc. | 10/18/1984SE |
| K841640 | Nova Balloon Thermodilution InfusionDYG · Traditional | Nova Medical Specialties | 08/12/1984SE |
| K841639 | Nova Balloon Thermodilution Cath.DYG · Traditional | Nova Medical Specialties | 08/12/1984SE |
| K841876 | Polyurethane Thermal Dilution CathetDYG · Traditional | Waters Instruments, Inc. | 07/13/1984SE |
| K841705 | Wedge Pressure Catheter Flow DirectedDYG · Traditional | Mansfield Scientific, Inc. | 07/13/1984SE |
| K841317 | Deseret Heparin Coated Flow DirectedDYG · Traditional | Parke-Davis Co. | 06/11/1984SE |
| K841251 | Deseret Heparin Coated Flow CathDYG · Traditional | Parke-Davis Co. | 06/11/1984SE |
| K833836 | Il Heparinized Flow Directed ThermalDYG · Traditional | Instrumentation Laboratory CO | 02/04/1984SE |
| K833918 | Infusion Port Balloon ThermodilutionDYG · Traditional | Critikon Company, LLC | 01/30/1984SE |
| K833572 | Heparin-Coated Balloon ThermodilutDYG · Traditional | Critikon Company, LLC | 01/30/1984SE |
| K834037 | Heparin Coated Balloon ThermodiluDYG · Traditional | Nova Medical Specialties | 01/10/1984SE |
| K834036 | Heparin Coated Balloon ThermodiluDYG · Traditional | Nova Medical Specialties | 01/10/1984SE |
| K832380 | Protective SleeveDYG · Traditional | Vertex Medical Corp. | 11/28/1983SE |
| K832324 | Thermal Dilution CatheterDYG · Traditional | Catheter Corp. of America | 11/03/1983SE |
| K831854 | Usci Angiographic Balloon CatheterDYG · Traditional | C.R. Bard, Inc. | 10/20/1983SE |
| K832287 | Nova Balloon Thermodilution InfusionDYG · Traditional | Nova Medical Specialties | 10/19/1983SE |
| K832957 | Flow-Directed Heparin Coated ThermodilDYG · Traditional | Sorensen Research | 09/29/1983SE |
| K831945 | Elecath Baltherm TLC Thermal DilutionDYG · Traditional | Electro-Catheter Corp. | 08/12/1983SE |
| K830604 | Wedge Pressure CatheterDYG · Traditional | Plasmedics, Inc. | 07/18/1983SE |
| K831185 | Cardiac Output Measure SystemDYG · Traditional | Cook, Inc. | 05/27/1983SE |
| K823484 | Thermal Dilution CatheterDYG · Traditional | Instrumentation Laboratory CO | 12/22/1982SE |
| K823433 | Balloon Thermodilution Catheter #7164&DYG · Traditional | Critikon Company, LLC | 11/30/1982SE |
| K823007 | Opticath Heparin Coated, Flow-DirectDYG · Traditional | Oximetrix, Inc. | 11/01/1982SE |
| K822806 | Balloon Wedge Pressure, AngiographicDYG · Traditional | Nova Medical Specialties | 11/01/1982SE |
| K822723 | Swan-Ganz Bipolar Pacing CatheterDYG · Traditional | American Edwards Laboratories | 10/15/1982SE |
| K822350 | Swan-Ganz Flow-Directed Thermodil. CathDYG · Traditional | American Edwards Laboratories | 08/24/1982SE |
| K822034 | Balloon Wedge Pressure CatheterDYG · Traditional | Ziehm International, Inc. | 08/24/1982SE |
| K821996 | Leonard Peripheral Venous Pressure CathDYG · Traditional | Norton Performance Plastics Corp. | 07/30/1982SE |
| K821004 | Medtronic S3 TM SystemDYG · Traditional | Medtronic Vascular | 05/25/1982SE |
| K821235 | Heparin Coated Thermodilution CatheterDYG · Traditional | Gould, Inc. | 05/18/1982SE |
| K821099 | Heparin Coated Thermodilution CatheterDYG · Traditional | Kma, Inc. | 05/18/1982SE |
| K821057 | Flow Directed Thermal-Dilution InfusionDYG · Traditional | Oximetrix, Inc. | 05/18/1982SE |
| K820883 | SeptisleeveDYG · Traditional | Argon Medical Corp. | 04/29/1982SE |
| K820702 | Il 7F Flow Director Thermal Dilu. CathDYG · Traditional | Instrumentation Laboratory CO | 04/21/1982SE |
| K820229 | Norton Flow Directed Thermodilution CathDYG · Traditional | Norton Performance Plastics Corp. | 02/12/1982SE |
| K820222 | Swan-Ganz Vip-CatheterDYG · Traditional | American Edwards Laboratories | 02/12/1982SE |
| K813578 | Hemostatic Side-Arm AdapterDYG · Traditional | Advanced Catheter Systems | 01/18/1982SE |
| K812111 | Pruitt Arterial Occlusion Cholang. CathDYG · Traditional | Bionomy, Inc. | 11/16/1981SE |
| K812563 | Swan-Ganz & Edslab Heparin Coated Cath.DYG · Traditional | American Edwards Laboratories | 09/25/1981SE |
| K812324 | Flow-Directed Thermodilution CatheterDYG · Traditional | Sorensen Research | 09/25/1981SE |
| K811276 | Occlusion CatheterDYG · Traditional | Bionomy, Inc. | 06/30/1981SE |
| K810352 | Swan-Ganz Flow-Directed ThermodilutionDYG · Traditional | American Edwards Laboratories | 03/27/1981SE |
| K810124 | Swan-Ganz Vip Thermodilution CatheterDYG · Traditional | American Edwards Laboratories | 02/04/1981SE |
| K802288 | Swan Ganz Catheter Placement KitDYG · Traditional | Stanco Medical, Inc. | 11/20/1980SE |
| K802481 | 7FRENCH Flow Directed Triple Lumen CathDYG · Traditional | Waters Assoc., Inc. | 10/31/1980SE |
| K802338 | Torque Control Balloon CatheterDYG · Traditional | Cordis Corp. | 10/10/1980SE |
| K801865 | Cordis Flow Directed Balloon CatheterDYG · Traditional | Cordis Corp. | 08/20/1980SE |
| K782071 | Catheter, Usci Gruntzig/BalloonDYG · Traditional | C.R. Bard, Inc. | 12/15/1978SE |
| K771823 | Catheter, CardiovascularDYG · Traditional | Usci, Div. C.R. Bard, Inc. | 12/20/1977SE |
| K771043 | Swan GanzDYG · Traditional | Clincal Instruments Corp. | 12/20/1977SE |
| K772059 | Catheter, Pacing/MonitoringDYG · Traditional | Electro-Catheter Corp. | 11/15/1977SE |
| K771306 | ThermocathDYG · Traditional | Victory Engineering Corp. | 09/14/1977SE |
| K770522 | Catheter, Gruntzig, BallonDYG · Traditional | Cook, Inc. | 03/30/1977SE |
| K760533 | Catheter, Flow Directed Thermal DilutionDYG · Traditional | Gould, Inc. | 09/09/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2204-2026 Class II | Swan-Ganz Pacing Catheter, Models: D200F7;Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal… | Becton, Dickinson and Company | 04/08/2026Open, Classified |
| Z-2203-2026 Class II | Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755PCatheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal… | Becton, Dickinson and Company | 04/08/2026Open, Classified |
| Z-1751-2025 Class II | Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36…During internal product testing, it was observed that some packages to have incomplete seals (sterile… | LeMaitre Vascular, Inc. | 04/11/2025Open, Classified |
| Z-1380-2023 Class II | Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution…There is a potential that the distal end of the catheter may be bent beyond its intended curvature and when… | Edwards Lifesciences, LLC | 02/14/2023Open, Classified |
| Z-1379-2023 Class II | Edward Lifesciences, REF 777F8, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution…There is a potential that the distal end of the catheter may be bent beyond its intended curvature and when… | Edwards Lifesciences, LLC | 02/14/2023Open, Classified |
| Z-0716-2020 Class II | Arrow Berman Angiographic Catheter 60cm Item Number: AI-07130-JPotential leak in the balloon extension line. If a leak was present and went undetected during pre-use… | Arrow International Inc | 11/15/2019Terminated |
| Z-0715-2020 Class II | Arrow Berman Angiographic Catheter 50cc Item Number: AI-07130Potential leak in the balloon extension line. If a leak was present and went undetected during pre-use… | Arrow International Inc | 11/15/2019Terminated |
| Z-0765-2019 Class I | Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 151F7 Product Usage: The…These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If the lumens… | Edwards Lifesciences, LLC | 12/21/2018Terminated |
| Z-0764-2019 Class I | Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131VF7P Product Usage: The…These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If the lumens… | Edwards Lifesciences, LLC | 12/21/2018Terminated |
| Z-0763-2019 Class I | Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131F7P (5 pack of 131F7)…These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If the lumens… | Edwards Lifesciences, LLC | 12/21/2018Terminated |
| Z-0762-2019 Class I | Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF131F 7J Product Usage: The…These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If the lumens… | Edwards Lifesciences, LLC | 12/21/2018Terminated |
| Z-1700-2015 Class II | Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75. Flow-directed…The product failed to meet the internal established statistical test requirement for heparin activity. | Edwards Lifesciences, LLC | 05/05/2015Terminated |
| Z-1057-2013 Class II | Arrow/Teleflex Medical Berman Angiographic Balloon Catheter and Reverse Berman…The product specifications sheet, part of the Instructions for Use (IFU), for the specified product numbers… | Arrow International Inc | 03/04/2013Terminated |
| Z-2198-2012 Class II | Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model TS057HF7. For use in…The device is being recalled because the firm received multiple complaints related to passage of a J-tip… | Edwards Lifesciences, LLC | 05/11/2012Terminated |
| Z-2197-2012 Class II | Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151HF7. For use in…The device is being recalled because the firm received multiple complaints related to passage of a J-tip… | Edwards Lifesciences, LLC | 05/11/2012Terminated |
| Z-2196-2012 Class II | Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151F7. For use in…The device is being recalled because the firm received multiple complaints related to passage of a J-tip… | Edwards Lifesciences, LLC | 05/11/2012Terminated |
| Z-2195-2012 Class II | Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7P. For use in…The device is being recalled because the firm received multiple complaints related to passage of a J-tip… | Edwards Lifesciences, LLC | 05/11/2012Terminated |
| Z-2192-2012 Class II | Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HVF7P. For use in…The device is being recalled because the firm received multiple complaints related to passage of a J-tip… | Edwards Lifesciences, LLC | 05/11/2012Terminated |
| Z-2191-2012 Class II | Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7P. For use in…The device is being recalled because the firm received multiple complaints related to passage of a J-tip… | Edwards Lifesciences, LLC | 05/11/2012Terminated |
| Z-2190-2012 Class II | Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7J. For use in…The device is being recalled because the firm received multiple complaints related to passage of a J-tip… | Edwards Lifesciences, LLC | 05/11/2012Terminated |
| Z-2189-2012 Class II | Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7P. For use in…The device is being recalled because the firm received multiple complaints related to passage of a J-tip… | Edwards Lifesciences, LLC | 05/11/2012Terminated |
| Z-2188-2012 Class II | Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7J. For use in…The device is being recalled because the firm received multiple complaints related to passage of a J-tip… | Edwards Lifesciences, LLC | 05/11/2012Terminated |
| Z-1243-2009 | Edwards Lifesciences Swan-Ganz CCOombo CCO/SvO2/VIP Thermodilution Catheter with AMC…Cardiac output measurements were unavailable and the following message is displayed in the Vigilance… | Edwards Lifesciences, Llc | 02/09/2009Terminated |
| Z-1242-2009 | Edwards Lifesciences Swan-Ganz CCOombo CCO/SvO2/VIP Thermodilution Catheter For use with…Cardiac output measurements were unavailable and the following message is displayed in the Vigilance… | Edwards Lifesciences, Llc | 02/09/2009Terminated |
| Z-1241-2009 | Edwards Lifesciences Swan-Ganz CCOombo CCO/SvO2 Thermodilution Catheter with AMC…Cardiac output measurements were unavailable and the following message is displayed in the Vigilance… | Edwards Lifesciences, Llc | 02/09/2009Terminated |
| Z-1116-2007 | Thermodilution Right Heart Catheters, Catalog Numbers 604028 and 604165. The product is…Cracks at the Catheter Tip | B. Braun Medical, Inc. | 06/05/2007Terminated |
| Z-0338-2007 | Edwards Lifesciences-Swan-Ganz,Thermodilution Venous Infusion Port (VIP) Catheter with…Misbranding-One lot of Swan-Ganz Thermodilution VIP Catheters, Model 831HF75, lot 246HC197 was labeled with… | Edwards Lifesciences Technology SARL | 11/27/2006Terminated |