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FDA 510(k) Applications Submitted by Aeree Lee
FDA 510(k) Number
Submission Date
Device Name
Applicant
K241330
05/10/2024
Fogarty Fortis Arterial Embolectomy Catheter
Edwards Lifesciences
K142427
08/29/2014
TISSUE CONTAINMENT SYSTEM; 10, 14, 17, 25
APPLIED MEDICAL RESOURCES
K242909
09/24/2024
FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors
Edwards Lifesciences, LLC
K233619
11/13/2023
Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters
Edwards Lifesciences
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