Cleared Traditional

Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters

K233619 · Edwards Lifesciences · Cardiovascular
May 2024
Decision
189d
Days
Class 2
Risk

About This 510(k) Submission

K233619 is an FDA 510(k) clearance for the Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters, a Catheter, Embolectomy (Class II — Special Controls, product code DXE), submitted by Edwards Lifesciences (Irvine, US). The FDA issued a Cleared decision on May 20, 2024, 189 days after receiving the submission on November 13, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number K233619 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 2023
Decision Date May 20, 2024
Days to Decision 189 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DXE — Catheter, Embolectomy
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5150

Similar Devices — DXE Catheter, Embolectomy

All 73
Fogarty Thru-Lumen Embolectomy Catheter
K240078 · Edwards Lifesciences, LLC · Aug 2024
Fogarty Fortis Arterial Embolectomy Catheter
K241330 · Edwards Lifesciences · Jul 2024
Fogarty Venous Thrombectomy Catheters
K233819 · Edwards Lifesciences, LLC · May 2024
Fogarty Arterial Embolectomy Catheter with Gate Valve
K233820 · Edwards Lifesciences · May 2024
Merlin Aspiration System
K213771 · Mivi Neurovascular, Inc. · Jan 2022
Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter
K202049 · Applied Medical Resources Corporation · Sep 2021

More from Edwards Lifesciences

View all
HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)
K252533 · DQK · Dec 2025
HemoSphere Stream Module
K253034 · DQK · Oct 2025
Edwards eSheath Optima introducer set
K252364 · DYB · Aug 2025
HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere ClearSight Module (HEMCSM10); Smart Pressure Controller (PC1Q); Acumen IQ Plus Finger Cuff (AIQCA2); HemoSphere Pressure Cable (HEMPSC100); HemoSphere Vita Monitor (HEMVITA1); HemoSphere Vita Technology Module (HEMVTOM1); HemoSphere VitaWave module (HEMVWM1); VitaWave Plus finger cuff (VWCA2)
K243781 · DQK · Jul 2025
Edwards eSheath Optima introducer set
K244046 · DYB · Mar 2025