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 |
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 |