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DXE — Catheter, Embolectomy Class II

FDA Device Classification

Classification Details

Product Code
DXE
Device Class
Class II
Regulation Number
870.5150
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K240078edwards lifesciencesFogarty Thru-Lumen Embolectomy CatheterAugust 28, 2024
K241330edwards lifesciencesFogarty Fortis Arterial Embolectomy CatheterJuly 2, 2024
K233820edwards lifesciencesFogarty Arterial Embolectomy Catheter with Gate ValveMay 22, 2024
K233819edwards lifesciencesFogarty Venous Thrombectomy CathetersMay 22, 2024
K233619edwards lifesciencesFogarty Corkscrew Catheters; Fogarty Graft Thrombectomy CathetersMay 20, 2024
K213771mivi neurovascularMerlin Aspiration SystemJanuary 27, 2022
K202049applied medical resources corporationPython Catheter/Over-the-Wire Latis Graft Cleaning CatheterSeptember 7, 2021
K193379edwards lifesciencesFogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon ProbeJune 12, 2020
K163031cook incorporatedBunegin-Albin Air Aspiration SetJuly 27, 2017
K163353cook incorporatedNeedle's Eye Snare Retrieval Set - 54cmJuly 11, 2017
K152335medtronicExport Advance Aspiration CatheterSeptember 18, 2015
K100840hotspur technologiesEMBO PLUS EMBOLECTOMY CATHETERJuly 12, 2010
K100842hotspur technologiesPTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CMJuly 12, 2010
K081573medtronic vascularMEDTRONIC EXPORT AP CATHETERJune 27, 2008
K022145lemaitre vascularOVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302January 14, 2003
K020634atrium medicalMODIFICATION TO ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETERMay 8, 2002
K011783pfm produkte fur die medizinMULTI-SNARE SETJanuary 24, 2002
K002627atrium medicalATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETERApril 26, 2001
K992933vascutechLEMAITRE IRRIGATION CATHETERMarch 8, 2000
K992934vascutechLEMAITRE VENOUS THROMBECTOMY CATHETERMarch 1, 2000