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510(k) K233824

Device
Swan-Ganz catheter
Applicant
Edwards Lifesciences, LLC
510(k) number
K233824
Product code
DYG
Decision
Substantially Equivalent (SESE)
Decision date
2024-06-06
Date received
2023-12-01
Regulation
870.1240
Classification name
Catheter, Flow Directed
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Bedalin Lugo Rodriguez
Address
One Edwards Way Irvine CA US 92614 92614

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DYG#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100)Edwards Lifesciences2024-12-09
K233983Swan-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 Lifesciences2024-06-27
K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring PlatformEdwards Lifesciencess, LLC2023-09-21
K222117Swang-Ganz IQ pulmonary artery catheterEdwards Lifesiences, LLC2022-12-09
K193466Swan-Ganz CathetersEdwards Lifesciences, LLC2020-02-16
K160084Swan Ganz CathetersEdwards Lifesciences, LLC2016-05-03
K094048PERCUPRO MESSENGER BALLOON CATHETERCardiosolutions, Inc.2011-07-14
K081052OCCLUSION BALLOON CATHETER, MODEL VENOSOscor, Inc.2008-06-18
K010253ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101Transonic Systems, Inc.2002-03-19
K012225ATTAIN 6215 VENOGRAM BALLOON CATHETERMedtronic Vascular2001-08-28
K003118Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0Zcv ,Inc.2000-12-20
K001063SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7Baxter Healthcare Corp2000-07-07
K993245CONTINOUS CARDIAC OUTPUT PULMONARY ARTERY CATHETER, MODEL TRUCATH, CONTINOUS CARDIAC OUTPUT MONITOR, MODEL TRUCCOMAlba Critical Care, Ltd.1999-10-28
K963336HARMAC THERMODILUTION CATHETERHarmac Medical Products, Inc.1997-08-14
K955816VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY (CCO/SVO2) MONITORBaxter Healthcare Corp1997-05-06