ClearanceBrief
Panels › Cardiovascular › Product code DYG · Class 2

Catheter, Flow Directed

Regulation 870.1240

0510(k)s in 12 months (99 all time)
2recalls in 12 months (49 all time)
47recalls that name a 510(k)
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Top companies in DYG

Company510(k)sRecalls
Edwards Lifesciences520
B. Braun Medical, Inc.021
Baxter Healthcare Corp70
Nova Medical Specialties70
American Edwards Laboratories60
C.R. Bard, Inc.40
J-Lloyd Medical, Inc.40
Medtronic Vascular40
Arrow International Inc03
Critikon Company, LLC30
Decided510(k)Device and applicantCode
Dec 9, 2024K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC
Edwards Lifesciences
DYG
Jun 27, 2024K233983Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D
Edwards Lifesciences
DYG
Jun 6, 2024K233824Swan-Ganz catheter
Edwards Lifesciences, LLC
DYG
Sep 21, 2023K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform
Edwards Lifesciencess, LLC
DYG
Dec 9, 2022K222117Swang-Ganz IQ pulmonary artery catheter
Edwards Lifesiences, LLC
DYG
Feb 16, 2020K193466Swan-Ganz Catheters
Edwards Lifesciences, LLC
DYG
May 3, 2016K160084Swan Ganz Catheters
Edwards Lifesciences, LLC
DYG
Jul 14, 2011K094048PERCUPRO MESSENGER BALLOON CATHETER
Cardiosolutions, Inc.
DYG
Jun 18, 2008K081052OCCLUSION BALLOON CATHETER, MODEL VENOS
Oscor, Inc.
DYG
Mar 19, 2002K010253ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101
Transonic Systems, Inc.
DYG
Aug 28, 2001K012225ATTAIN 6215 VENOGRAM BALLOON CATHETER
Medtronic Vascular
DYG
Dec 20, 2000K003118Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0
Zcv ,Inc.
DYG
Jul 7, 2000K001063SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7
Baxter Healthcare Corp
DYG
Oct 28, 1999K993245CONTINOUS CARDIAC OUTPUT PULMONARY ARTERY CATHETER, MODEL TRUCATH, CONTINOUS CARDIAC OUTPUT MONITOR, MODEL TRUCCOM
Alba Critical Care, Ltd., GB
DYG
Aug 14, 1997K963336HARMAC THERMODILUTION CATHETER
Harmac Medical Products, Inc.
DYG
May 6, 1997K955816VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY (CCO/SVO2) MONITOR
Baxter Healthcare Corp
DYG
Feb 3, 1997K963248FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575-110P)
J-Lloyd Medical, Inc.
DYG
Nov 19, 1996K961999SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS
Boston Scientific Scimed, Inc.
DYG
Nov 27, 1995K951566SWAN-GANZE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS INFUSION PORT/EJECTION FRACTION/VOLUMETRIC (CCO/SVO2/VIP/REF) CATH]
Baxter Healthcare Corp
DYG
Aug 11, 1994K940547FLOW DIRECT THERMODILUT BALLOON CATH HEPARIN COATED
J-Lloyd Medical, Inc.
DYG
May 24, 1994K940795SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETER
Baxter Edwards
DYG
May 3, 1994K935404FLOW DIRECTED THERMODILUTION BALLOON CATHETER
J-Lloyd Medical, Inc.
DYG
Jan 24, 1994K934742SWAN-GANZ CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS PORT
Baxter Healthcare Corp
DYG
Oct 29, 1993K924452SWAN-GANZ CCO/SVO2 THERMODILUTION CATHETER
Baxter Healthcare Corp
DYG
Jul 19, 1993K925444CARDIAC OUTPUT PULMONARY ARTERY CATHETER & MONITOR
Ami-Med Corp.
DYG
Jan 13, 1993K920869FLOW DIRECTED THERMODILUTION BALLOON CATHETER
J-Lloyd Medical, Inc.
DYG
Jun 3, 1991K911840INTERFLO MEDICAL MODEL PA3-H CCO/PAC CATHETER
Intec Medical, Inc.
DYG
Feb 20, 1991K901287INTHERM TEMPORARY OCCLUSION CATHETER
Interventional Therapeutics Corp.
DYG
Jan 16, 1991K904287STEALTH DILATION CATHETER SYSTEM/MODIFICATION
Target Therapeutics
DYG
Jul 31, 1990K901247TRI ADAPTER W/ADJUSTABLE HEMOSTASIS VALVES
Intec Medical, Inc.
DYG
May 10, 1990K900879SOFT-WEDGE(TM) SYRINGE
Baxter Healthcare Corp
DYG
Feb 8, 1990K896466SWAN-GANZ THERMODILUTION EJECTION FRACTION/VOLUME
Baxter Healthcare Corp
DYG
Sep 26, 1989K893435SILICONE FLOW-DIRECTED THERMODILUTION CATHETER
Cathlab Corp.
DYG
Sep 26, 1989K892530CATHETERS FOR BALLOON OCCLUSION FEMORAL ANGIOGRAPH
Arrow Intl., Inc.
DYG
Sep 5, 1989K893474BARD CATH LAB THERMODILUTION CATHETER
C.R. Bard, Inc.
DYG
Apr 21, 1989K883948MODIFIED NUMED BALLOON ANGIOGRAPHIC CATHETER
NuMED, Inc.
DYG
May 25, 1988K874465SORENSON THERMO. FLOW-DIRECT TRANS PACE CATH/LEAD
Abbott Laboratories
DYG
Nov 5, 1987K874117MEDTRONIC MODEL 6550 ADJUSTABLE HEMOSTASIS VALVE
Medtronic Vascular
DYG
Oct 15, 1987K872770DUAL-THERMISTOR THERMODILUTION CATH. & INFU. CATH.
Nova Medical Specialties
DYG
Aug 29, 1986K862119DESERET FLO-THRU INJECTATE TEMPERATURE SENSOR
Parke-Davis Co.
DYG
Dec 3, 1985K853383CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SIN
Webster Laboratories, Inc.
DYG
Sep 17, 1985K852294BARD-PARKER OCCLUSION BALLOON CATHETER
Bd Becton Dickinson Vacutainer Systems Preanalytic
DYG
Aug 5, 1985K850952BARD CRITICAL CARE THERMODILUTIN CATHETER W/INFUSI
C.R. Bard, Inc.
DYG
Jun 20, 1985K851948MEDTRONIC MODEL 6404
Medtronic Vascular
DYG
Oct 18, 1984K843411THERMAL DILUTION CATHETER
Andover Medical, Inc.
DYG
Oct 18, 1984K843409FLOW-DIRECTED THERMODILUTION CATH
Andover Medical, Inc.
DYG
Aug 12, 1984K841640NOVA BALLOON THERMODILUTION INFUSION
Nova Medical Specialties
DYG
Aug 12, 1984K841639NOVA BALLOON THERMODILUTION CATH.
Nova Medical Specialties
DYG
Jul 13, 1984K841876POLYURETHANE THERMAL DILUTION CATHET
Waters Instruments, Inc.
DYG
Jul 13, 1984K841705WEDGE PRESSURE CATHETER FLOW DIRECTED
Mansfield Scientific, Inc.
DYG

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