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510(k) K233619

Device
Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters
Applicant
Edwards Lifesciences
510(k) number
K233619
Product code
DXE
Decision
Substantially Equivalent (SESE)
Decision date
2024-05-20
Date received
2023-11-13
Regulation
870.5150
Classification name
Catheter, Embolectomy
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Aeree Lee
Address
1 Edwards Way Irvine CA US 92614 92614

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DXE#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K240078Fogarty Thru-Lumen Embolectomy CatheterEdwards Lifesciences, LLC2024-08-28
K241330Fogarty Fortis Arterial Embolectomy CatheterEdwards Lifesciences2024-07-02
K233819Fogarty Venous Thrombectomy CathetersEdwards Lifesciences, LLC2024-05-22
K233820Fogarty Arterial Embolectomy Catheter with Gate ValveEdwards Lifesciences2024-05-22
K213771Merlin Aspiration SystemMivi Neurovascular, Inc.2022-01-27
K202049Python Catheter/Over-the-Wire Latis Graft Cleaning CatheterApplied Medical Resources Corporation2021-09-07
K193379Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon ProbeEdwards Lifesciences, LLC2020-06-12
K163031Bunegin-Albin Air Aspiration SetCook Incorporated2017-07-27
K163353Needle's Eye Snare Retrieval Set - 54cmCook Incorporated2017-07-11
K152335Export Advance Aspiration CatheterMedtronic, Inc.2015-09-18
K100840EMBO PLUS EMBOLECTOMY CATHETERHotspur Technologies2010-07-12
K100842PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CMHotspur Technologies2010-07-12
K081573MEDTRONIC EXPORT AP CATHETERMedtronic Vascular2008-06-27
K022145OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302LeMaitre Vascular, Inc.2003-01-14
K020634MODIFICATION TO ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETERAtrium Medical Corp.2002-05-08