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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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