FDA 510(k) Applications for Medical Device Product Code "DYG"
(Catheter, Flow Directed)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K993245 | ALBA CRITICAL CARE LTD | CONTINOUS CARDIAC OUTPUT PULMONARY ARTERY CATHETER, MODEL TRUCATH, CONTINOUS CARDIAC OUTPUT MONITOR, MODEL TRUCCOM | 10/28/1999 |
| K001063 | BAXTER HEALTHCARE CORP. | SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7 | 07/07/2000 |
| K955816 | BAXTER HEALTHCARE CORP. | VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY (CCO/SVO2) MONITOR | 05/06/1997 |
| K961999 | BOSTON SCIENTIFIC SCIMED, INC. | SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS | 11/19/1996 |
| K094048 | CARDIOSOLUTIONS INC | PERCUPRO MESSENGER BALLOON CATHETER | 07/14/2011 |
| K242451 | Edwards LifeSciences | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100) | 12/09/2024 |
| K233983 | Edwards Lifesciences | 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) | 06/27/2024 |
| K233824 | Edwards Lifesciences LLC | Swan-Ganz catheter | 06/06/2024 |
| K160084 | Edwards Lifesciences, LLC | Swan Ganz Catheters | 05/03/2016 |
| K193466 | Edwards Lifesciences, LLC | Swan-Ganz Catheters | 02/16/2020 |
| K231248 | Edwards Lifesciencess LLC | Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform | 09/21/2023 |
| K222117 | Edwards Lifesiences, LLC | Swang-Ganz IQ pulmonary artery catheter | 12/09/2022 |
| K963336 | HARMAC MEDICAL PRODUCTS, INC. | HARMAC THERMODILUTION CATHETER | 08/14/1997 |
| K963248 | J-LLOYD MEDICAL, INC. | FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575-110P) | 02/03/1997 |
| K012225 | MEDTRONIC VASCULAR | ATTAIN 6215 VENOGRAM BALLOON CATHETER | 08/28/2001 |
| K081052 | Oscor Inc. | OCCLUSION BALLOON CATHETER, MODEL VENOS | 06/18/2008 |
| K010253 | TRANSONIC SYSTEMS, INC. | ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101 | 03/19/2002 |
| K003118 | ZCV ,INC. | Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0 | 12/20/2000 |
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