DXE · Class II · 21 CFR 870.5150

FDA Product Code DXE: Catheter, Embolectomy

Leading manufacturers include Edwards Lifesciences, LLC, Edwards Lifesciences and Cook Incorporated.

74
Total
74
Cleared
148d
Avg days
1976
Since
Declining activity - 2 submissions in the last 2 years vs 3 in the prior period
Consistent review times: 142d avg (recent)

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 Jun 27, 2008
MEDTRONIC EXPORT AP CATHETER
K081573
Medtronic Vascular
Cardiovascular · 22d
Cleared Jul 06, 1990
FOGARTY ARTERIAL EMBOLECTOMY II CATHETER
K901625
Baxter Healthcare Corp
Cardiovascular · 88d
Cleared Jul 20, 1989
FOGARTY(R) THRU-LUMEN EMBOLECTOMY CATHETER
K892410
Baxter Healthcare Corp
Cardiovascular · 104d

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 - 2 submissions in the last 24 months compared to 3 in the prior period.

FDA 510(k) Review Time - DXE Product Code

FDA review times for DXE submissions have been consistent, averaging 142 days recently vs 148 days historically.

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