DXE · Class II · 21 CFR 870.5150

FDA Product Code DXE: Catheter, Embolectomy

Leading manufacturers include Shiley, Inc., Edwards Lifesciences, LLC and Edwards Lifesciences.

74
Total
74
Cleared
148d
Avg days
1976
Since
Declining activity - 1 submissions in the last 2 years vs 4 in the prior period
Review times increasing: avg 230d recently vs 147d historically

FDA 510(k) Cleared Catheter, Embolectomy Devices (Product Code DXE)

74 devices
1–24 of 74
Cleared Aug 28, 2024
Fogarty Thru-Lumen Embolectomy Catheter
K240078
Edwards Lifesciences, LLC
Cardiovascular · 230d
Cleared Jul 02, 2024
Fogarty Fortis Arterial Embolectomy Catheter
K241330
Edwards Lifesciences
Cardiovascular · 53d
Cleared May 22, 2024
Fogarty Venous Thrombectomy Catheters
K233819
Edwards Lifesciences, LLC
Cardiovascular · 173d
Cleared May 22, 2024
Fogarty Arterial Embolectomy Catheter with Gate Valve
K233820
Edwards Lifesciences
Cardiovascular · 173d
Cleared May 20, 2024
Fogarty Corkscrew Catheters
K233619
Edwards Lifesciences
Cardiovascular · 189d
Cleared Jan 27, 2022
Merlin Aspiration System
K213771
Mivi Neurovascular, Inc.
Cardiovascular · 56d
Cleared Sep 07, 2021
Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter
K202049
Applied Medical Resources Corporation
Cardiovascular · 410d
Cleared Jun 12, 2020
Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe
K193379
Edwards Lifesciences, LLC
Cardiovascular · 190d
Cleared Jul 27, 2017
Bunegin-Albin Air Aspiration Set
K163031
Cook Incorporated
Cardiovascular · 269d
Cleared Jul 11, 2017
Needle's Eye Snare Retrieval Set - 54cm
K163353
Cook Incorporated
Cardiovascular · 223d
Cleared Sep 18, 2015
Export Advance Aspiration Catheter
K152335
Medtronic, Inc.
Cardiovascular · 30d
Cleared Jun 27, 2008
MEDTRONIC EXPORT AP CATHETER
K081573
Medtronic Vascular
Cardiovascular · 22d
Cleared May 08, 2002
MODIFICATION TO ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER
K020634
Atrium Medical Corp.
Cardiovascular · 70d
Cleared Apr 26, 2001
ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER
K002627
Atrium Medical Corp.
Cardiovascular · 246d
Cleared Aug 31, 1998
ARROW 5FX60CM BALLOON EMBOLECTOMY CATHETER, MODEL # EM-56025
K982141
Arrow Intl., Inc.
Cardiovascular · 75d
Cleared Mar 17, 1998
DCAT EMBOLECTOMY CATHETER SYSTEM
K971314
AngioDynamics, Inc.
Cardiovascular · 342d
Cleared Feb 19, 1998
LATIS GRAFT CLEANING CATHETER
K973465
Applied Medical Resources
Cardiovascular · 160d
Cleared Mar 28, 1997
DUAL LUMEN EMBOLECTOMY CATHETER
K970762
Applied Medical Resources
Cardiovascular · 25d
Cleared May 15, 1995
AVD INTIMAX THROMBECTOMY CATHETER
K950586
Applied Medical Resources
Cardiovascular · 95d
Cleared Mar 04, 1993
WELTER SNARE RETRIEVER
K920823
Cook, Inc.
Cardiovascular · 374d
Cleared Jul 06, 1990
FOGARTY ARTERIAL EMBOLECTOMY II CATHETER
K901625
Baxter Healthcare Corp
Cardiovascular · 88d
Cleared Oct 12, 1989
REVISED LABELING FOR ARTERIAL EMBOLECTOMY CATHETER
K894681
Shiley, Inc.
Cardiovascular · 79d
Cleared Jul 20, 1989
FOGARTY(R) THRU-LUMEN EMBOLECTOMY CATHETER
K892410
Baxter Healthcare Corp
Cardiovascular · 104d
Cleared Jan 06, 1987
SHEAR FORCE GAUGE
K864330
American Edwards Laboratories
Cardiovascular · 63d

About Product Code DXE - Regulatory Context

510(k) Submission Activity

74 total 510(k) submissions under product code DXE since 1976, with 74 receiving FDA clearance (average review time: 148 days).

Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 4 in the prior period.

FDA 510(k) Review Time - DXE Product Code

Recent submissions under DXE have taken an average of 230 days to reach a decision - up from 147 days historically. Manufacturers should account for longer review timelines in current project planning.

DXE devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →