ClearanceBrief
Panels › Cardiovascular › Product code DXE · Class 2

Catheter, Embolectomy

Regulation 870.5150

0510(k)s in 12 months (74 all time)
2recalls in 12 months (58 all time)
56recalls that name a 510(k)
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Top companies in DXE

Company510(k)sRecalls
LeMaitre Vascular, Inc.123
Arrow International Inc010
Edwards Lifesciences64
Applied Medical Resources44
Boston Scientific Corporation05
Shiley, Inc.50
Cathlab Corp.40
Ideas For Medicine, Inc.40
Lucas Medical, Inc.40
Vascutech, Inc.40
Decided510(k)Device and applicantCode
Aug 28, 2024K240078Fogarty Thru-Lumen Embolectomy Catheter
Edwards Lifesciences, LLC
DXE
Jul 2, 2024K241330Fogarty Fortis Arterial Embolectomy Catheter
Edwards Lifesciences
DXE
May 22, 2024K233820Fogarty Arterial Embolectomy Catheter with Gate Valve
Edwards Lifesciences
DXE
May 22, 2024K233819Fogarty Venous Thrombectomy Catheters
Edwards Lifesciences, LLC
DXE
May 20, 2024K233619Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters
Edwards Lifesciences
DXE
Jan 27, 2022K213771Merlin Aspiration System
Mivi Neurovascular, Inc.
DXE
Sep 7, 2021K202049Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter
Applied Medical Resources Corporation
DXE
Jun 12, 2020K193379Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe
Edwards Lifesciences, LLC
DXE
Jul 27, 2017K163031Bunegin-Albin Air Aspiration Set
Cook Incorporated
DXE
Jul 11, 2017K163353Needle's Eye Snare Retrieval Set - 54cm
Cook Incorporated
DXE
Sep 18, 2015K152335Export Advance Aspiration Catheter
Medtronic, Inc.
DXE
Jul 12, 2010K100842PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CM
Hotspur Technologies
DXE
Jul 12, 2010K100840EMBO PLUS EMBOLECTOMY CATHETER
Hotspur Technologies
DXE
Jun 27, 2008K081573MEDTRONIC EXPORT AP CATHETER
Medtronic Vascular
DXE
Jan 14, 2003K022145OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302
LeMaitre Vascular, Inc.
DXE
May 8, 2002K020634MODIFICATION TO ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER
Atrium Medical Corp.
DXE
Jan 24, 2002K011783MULTI-SNARE SET
Pfm Produkte Fur Die Medizin AG
DXE
Apr 26, 2001K002627ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER
Atrium Medical Corp.
DXE
Mar 8, 2000K992933LEMAITRE IRRIGATION CATHETER
Vascutech, Inc.
DXE
Mar 1, 2000K992934LEMAITRE VENOUS THROMBECTOMY CATHETER
Vascutech, Inc.
DXE
Feb 22, 2000K992940LEMAITRE BALLOON CATHETER WITH IRRIGATION
Vascutech, Inc.
DXE
Dec 9, 1999K992368LEMAITRE EMBOLECTOMY CATHETER
Vascutech, Inc.
DXE
Sep 4, 1998K973477BIOSENSORS EMBOLECTOMY CATHETER
Sunscope Intl., Inc.
DXE
Aug 31, 1998K982141ARROW 5FX60CM BALLOON EMBOLECTOMY CATHETER, MODEL # EM-56025
Arrow Intl., Inc.
DXE
Mar 17, 1998K971314DCAT EMBOLECTOMY CATHETER SYSTEM
AngioDynamics, Inc.
DXE
Mar 6, 1998K972511AMPLATZ GOOSE NECK SNARE KIT/ CATHETER
Microvena Corp.
DXE
Feb 19, 1998K973465LATIS GRAFT CLEANING CATHETER
Applied Medical Resources
DXE
Feb 13, 1998K974335EMBOLECTOMY, IRRIGATION - OCCLUSION BALLOON CATHETER BY J-LLOYD MEDICAL, INC.
J-Lloyd Medical, Inc.
DXE
Jan 13, 1998K972572SINGLE LUMEN EMBOLECTOMY CATHETER
American Biomed, Inc.
DXE
Nov 19, 1997K972623LMI IRRIGATION CATHETER (IGR)
Lucas Medical, Inc.
DXE
Jul 1, 1997K970657LMI THROMBECTOMY CATHETER
Lucas Medical, Inc.
DXE
Mar 28, 1997K970762DUAL LUMEN EMBOLECTOMY CATHETER
Applied Medical Resources
DXE
Jan 13, 1997K961883VERSA-CATH ARTERIAL CATHETER
Ideas For Medicine, Inc.
DXE
Dec 27, 1996K961992NEEDLE'S EYE SNARE
Cook Pacemaker Corp.
DXE
Sep 19, 1996K961716VASO-SAFE ARTERIAL EMBOLECTOMY CATHETE
Ideas For Medicine, Inc.
DXE
Apr 11, 1996K954760LMI ARTERIAL EMBOLECTOMY CATHETER
Lucas Medical, Inc.
DXE
Mar 11, 1996K955125LMI OCCLUSION CATHETER
Lucas Medical, Inc.
DXE
May 15, 1995K950586AVD INTIMAX THROMBECTOMY CATHETER
Applied Medical Resources
DXE
Jul 25, 1994K935405ARTERIAL EMBOLECTOMY
J-Lloyd Medical, Inc.
DXE
Mar 4, 1993K920823WELTER SNARE RETRIEVER
Cook, Inc.
DXE
Feb 26, 1993K920871J-LLOYD ARTERIAL EMBOLECTOMY CATHETER
J-Lloyd Medical, Inc.
DXE
Mar 16, 1992K914880DUAL BALLOON EMBOLECTOMY CATHETER
Ideal Medical, Inc.
DXE
Apr 26, 1991K910372INTIMAX THROMBECTOMY CATHETER
Applied Vascular Devices, Inc.
DXE
Feb 25, 1991K905139CATHLAB SILICONE ARTERIAL EMBOLECTOMY CATHETER
Cathlab Corp.
DXE
Feb 25, 1991K902327EMBOLECTOMY CATHETER
Clincal Instruments Corp.
DXE
Dec 3, 1990K901502AMPLATZ GOOSE-NECK SNARE
Microvena Corp.
DXE
Oct 19, 1990K901627ARTERIAL EMBOLECTOMY CATHETER
Applied Vascular Devices, Inc.
DXE
Jul 17, 1990K900311ARTERIAL EMBOLECTOMY CATHETER
Impra, Inc.
DXE
Jul 6, 1990K901625FOGARTY ARTERIAL EMBOLECTOMY II CATHETER
Baxter Healthcare Corp
DXE
Mar 14, 1990K8971843F AND 4F IRRIGATION EMBOLECTOMY CATHETERS
Cathlab Corp.
DXE

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