FDA 510(k) Applications Submitted by EDWARDS LIFESCIENCES

FDA 510(k) Number Submission Date Device Name Applicant
K153069 10/22/2015 Edwards Balloon Catheter EDWARDS LIFESCIENCES
K152225 08/07/2015 Edwards eSheath Introducer Set EDWARDS LIFESCIENCES
DEN190029 06/03/2019 Acumen Assisted Fluid Management (AFM) Software Feature Edwards Lifesciences
K110597 03/02/2011 EV1000 CLINICAL PLATFORM EDWARDS LIFESCIENCES
K141696 06/24/2014 EDWARDS ESHEATH INTRODUCER SET EDWARDS LIFESCIENCES
K142199 08/11/2014 Ascendra Balloon Aortic Valvaloplasty Catheter EDWARDS LIFESCIENCES
K200258 02/03/2020 Edwards eSheath Introducer Set Edwards Lifesciences


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