FDA 510(k) Applications Submitted by EDWARDS LIFESCIENCES LLC

FDA 510(k) Number	Submission Date	Device Name	Applicant
K200358	02/13/2020	Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous Cannula, FemTrak Femoral Venous Cannula	Edwards Lifesciences LLC
K222216	07/25/2022	TruWave Disposable Pressure Transducer	Edwards Lifesciences LLC
K200499	02/28/2020	QuickDraw Venous Cannula	Edwards Lifesciences LLC
K180275	01/31/2018	VAMP Optima closed blood sampling system	Edwards Lifesciences LLC
K161962	07/18/2016	VAMP Venous/Arterial Blood Management Protection System	Edwards Lifesciences LLC
DEN160044	09/26/2016	Acumen Hypotension Prediction Index (HPI) Feature Software	Edwards Lifesciences LLC
K163693	12/28/2016	IntraClude Intra-Aortic Occlusion Device	Edwards Lifesciences LLC
K192762	09/30/2019	Physio Flex Annuloplasty Ring	Edwards Lifesciences LLC
K231035	04/11/2023	FusedCO Algorithm	Edwards Lifesciences LLC
K110103	01/13/2011	EDWARDS LIFESCIENCES LEFT ATRIAL PRESSURE MONITOR CATHETER	EDWARDS LIFESCIENCES LLC
K230057	01/09/2023	Acumen Hypotension Prediction Index (HPI) Algorithm	Edwards Lifesciences LLC