DXE · Class II · 21 CFR 870.5150

FDA Product Code DXE: Catheter, Embolectomy

Leading manufacturers include Shiley, Inc., Vascutech, Inc. and Lucas Medical, Inc..

74
Total
74
Cleared
148d
Avg days
1976
Since
Declining activity - 0 submissions in the last 2 years vs 5 in the prior period

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 Jan 14, 2003
OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302
K022145
LeMaitre Vascular, Inc.
Cardiovascular · 196d
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 Mar 08, 2000
LEMAITRE IRRIGATION CATHETER
K992933
Vascutech, Inc.
Cardiovascular · 190d
Cleared Mar 01, 2000
LEMAITRE VENOUS THROMBECTOMY CATHETER
K992934
Vascutech, Inc.
Cardiovascular · 183d
Cleared Feb 22, 2000
LEMAITRE BALLOON CATHETER WITH IRRIGATION
K992940
Vascutech, Inc.
Cardiovascular · 175d
Cleared Dec 09, 1999
LEMAITRE EMBOLECTOMY CATHETER
K992368
Vascutech, Inc.
Cardiovascular · 147d
Cleared Sep 04, 1998
BIOSENSORS EMBOLECTOMY CATHETER
K973477
Sunscope Intl., Inc.
Cardiovascular · 354d
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 Mar 06, 1998
AMPLATZ GOOSE NECK SNARE KIT/ CATHETER
K972511
Microvena Corp.
Cardiovascular · 246d
Cleared Feb 19, 1998
LATIS GRAFT CLEANING CATHETER
K973465
Applied Medical Resources
Cardiovascular · 160d

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 - 0 submissions in the last 24 months compared to 5 in the prior period.