Product Code: DYG FDA class 2 21 CFR 870.1240

Catheter, Flow Directed

Cardiovascular

The Flow-Directed Catheter is a cardiovascular device designed to be carried by blood flow to the right heart and pulmonary artery, commonly used to measure pulmonary arterial pressures and cardiac output in hemodynamic monitoring. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) clearance before marketing. The product code is DYG and the applicable regulation is 21 CFR 870.1240, under the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: DYG
Device Class: FDA class 2
Regulation Number: 870.1240
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 99 510(k) clearances via K numbers.

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