Cleared Traditional

Fogarty Fortis Arterial Embolectomy Catheter

K241330 · Edwards Lifesciences · Cardiovascular
Jul 2024
Decision
53d
Days
Class 2
Risk

About This 510(k) Submission

K241330 is an FDA 510(k) clearance for the Fogarty Fortis Arterial Embolectomy Catheter, a Catheter, Embolectomy (Class II — Special Controls, product code DXE), submitted by Edwards Lifesciences (Irvine, US). The FDA issued a Cleared decision on July 2, 2024, 53 days after receiving the submission on May 10, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number K241330 FDA.gov
FDA Decision Cleared SESE
Date Received May 10, 2024
Decision Date July 02, 2024
Days to Decision 53 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 Venous Thrombectomy Catheters
K233819 · Edwards Lifesciences, LLC · May 2024
Fogarty Arterial Embolectomy Catheter with Gate Valve
K233820 · Edwards Lifesciences · May 2024
Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters
K233619 · 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