DXE

ARTERIAL EMBOLECTOMY CATHETER

Advisory panel: Cardiovascular
Total cleared: 74

Adverse events under product code DXE

product code DXE

Death: 27
Injury: 258
Malfunction: 2,266
Total: 2,551

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code DXE

K240078 — Fogarty Thru-Lumen Embolectomy Catheter Edwards Lifesciences, LLC · 2024-08-28
K241330 — Fogarty Fortis Arterial Embolectomy Catheter Edwards Lifesciences · 2024-07-02
K233819 — Fogarty Venous Thrombectomy Catheters Edwards Lifesciences, LLC · 2024-05-22
K233820 — Fogarty Arterial Embolectomy Catheter with Gate Valve Edwards Lifesciences · 2024-05-22
K233619 — Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters Edwards Lifesciences · 2024-05-20
K213771 — Merlin Aspiration System Mivi Neurovascular, Inc. · 2022-01-27
K202049 — Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter Applied Medical Resources Corporation · 2021-09-07
K193379 — Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe Edwards Lifesciences, LLC · 2020-06-12
K163031 — Bunegin-Albin Air Aspiration Set Cook Incorporated · 2017-07-27
K163353 — Needle's Eye Snare Retrieval Set - 54cm Cook Incorporated · 2017-07-11
K152335 — Export Advance Aspiration Catheter Medtronic, Inc. · 2015-09-18
K100840 — EMBO PLUS EMBOLECTOMY CATHETER Hotspur Technologies · 2010-07-12
K100842 — PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CM Hotspur Technologies · 2010-07-12
K081573 — MEDTRONIC EXPORT AP CATHETER Medtronic Vascular · 2008-06-27
K022145 — OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302 LeMaitre Vascular, Inc. · 2003-01-14
K020634 — MODIFICATION TO ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER Atrium Medical Corp. · 2002-05-08
K011783 — MULTI-SNARE SET Pfm Produkte Fur Die Medizin AG · 2002-01-24
K002627 — ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER Atrium Medical Corp. · 2001-04-26
K992933 — LEMAITRE IRRIGATION CATHETER Vascutech, Inc. · 2000-03-08
K992934 — LEMAITRE VENOUS THROMBECTOMY CATHETER Vascutech, Inc. · 2000-03-01
K992940 — LEMAITRE BALLOON CATHETER WITH IRRIGATION Vascutech, Inc. · 2000-02-22
K992368 — LEMAITRE EMBOLECTOMY CATHETER Vascutech, Inc. · 1999-12-09
K973477 — BIOSENSORS EMBOLECTOMY CATHETER Sunscope Intl., Inc. · 1998-09-04
K982141 — ARROW 5FX60CM BALLOON EMBOLECTOMY CATHETER, MODEL # EM-56025 Arrow Intl., Inc. · 1998-08-31
K971314 — DCAT EMBOLECTOMY CATHETER SYSTEM AngioDynamics, Inc. · 1998-03-17
K972511 — AMPLATZ GOOSE NECK SNARE KIT/ CATHETER Microvena Corp. · 1998-03-06
K973465 — LATIS GRAFT CLEANING CATHETER Applied Medical Resources · 1998-02-19
K974335 — EMBOLECTOMY, IRRIGATION - OCCLUSION BALLOON CATHETER BY J-LLOYD MEDICAL, INC. J-Lloyd Medical, Inc. · 1998-02-13
K972572 — SINGLE LUMEN EMBOLECTOMY CATHETER American Biomed, Inc. · 1998-01-13
K972623 — LMI IRRIGATION CATHETER (IGR) Lucas Medical, Inc. · 1997-11-19
K970657 — LMI THROMBECTOMY CATHETER Lucas Medical, Inc. · 1997-07-01
K970762 — DUAL LUMEN EMBOLECTOMY CATHETER Applied Medical Resources · 1997-03-28
K961883 — VERSA-CATH ARTERIAL CATHETER Ideas For Medicine, Inc. · 1997-01-13
K961992 — NEEDLE'S EYE SNARE Cook Pacemaker Corp. · 1996-12-27
K961716 — VASO-SAFE ARTERIAL EMBOLECTOMY CATHETE Ideas For Medicine, Inc. · 1996-09-19
K954760 — LMI ARTERIAL EMBOLECTOMY CATHETER Lucas Medical, Inc. · 1996-04-11
K955125 — LMI OCCLUSION CATHETER Lucas Medical, Inc. · 1996-03-11
K950586 — AVD INTIMAX THROMBECTOMY CATHETER Applied Medical Resources · 1995-05-15
K935405 — ARTERIAL EMBOLECTOMY J-Lloyd Medical, Inc. · 1994-07-25
K920823 — WELTER SNARE RETRIEVER Cook, Inc. · 1993-03-04
K920871 — J-LLOYD ARTERIAL EMBOLECTOMY CATHETER J-Lloyd Medical, Inc. · 1993-02-26
K914880 — DUAL BALLOON EMBOLECTOMY CATHETER Ideal Medical, Inc. · 1992-03-16
K910372 — INTIMAX THROMBECTOMY CATHETER Applied Vascular Devices, Inc. · 1991-04-26
K902327 — EMBOLECTOMY CATHETER Clincal Instruments Corp. · 1991-02-25
K905139 — CATHLAB SILICONE ARTERIAL EMBOLECTOMY CATHETER Cathlab Corp. · 1991-02-25
K901502 — AMPLATZ GOOSE-NECK SNARE Microvena Corp. · 1990-12-03
K901627 — ARTERIAL EMBOLECTOMY CATHETER Applied Vascular Devices, Inc. · 1990-10-19
K900311 — ARTERIAL EMBOLECTOMY CATHETER Impra, Inc. · 1990-07-17
K901625 — FOGARTY ARTERIAL EMBOLECTOMY II CATHETER Baxter Healthcare Corp · 1990-07-06
K897184 — 3F AND 4F IRRIGATION EMBOLECTOMY CATHETERS Cathlab Corp. · 1990-03-14
K883852 — CATHETER, CARDIOVASCULAR, BALLOON TYPE Wb Intl., Inc. · 1989-12-07
K894681 — REVISED LABELING FOR ARTERIAL EMBOLECTOMY CATHETER Shiley, Inc. · 1989-10-12
K891021 — TRI-LUMEN INTRA VASCULAR BALLOON CATHETER Ideal Medical, Inc. · 1989-09-18
K893680 — SILICONE BI-LUMEN IRRIGATION EMBOLECTOMY CATH. Cathlab Corp. · 1989-08-01
K892410 — FOGARTY(R) THRU-LUMEN EMBOLECTOMY CATHETER Baxter Healthcare Corp · 1989-07-20
K881455 — EMBOLECTOMY CATHETER(MODIFIED) Cathlab Corp. · 1988-06-15
K872485 — CHANGE OF CATHETER BODY MATERIAL (RADIO-OPAQUE NY) Ideas For Medicine, Inc. · 1987-08-12
K864062 — PRUITT EMBOLECTOMY/IRRIGATION CATHETER (MODIFIED) Ideas For Medicine, Inc. · 1987-01-06
K864330 — SHEAR FORCE GAUGE American Edwards Laboratories · 1987-01-06
K864007 — EMBOLECTOMY/THROMBECTOMY BALLOON CATHETER Uresil Corp. · 1987-01-02
K853625 — NOVA ARTERIAL EMBOLECTOMY CATHETER Nova Medical Specialties · 1986-01-15
K850015 — POLYMED LAB ARTERIAL EMBOLECTOMY CATHETER Polymed Laboratories · 1985-06-19
K840198 — ARTERIAL EMBOLECTOMY CATHETER Shiley, Inc. · 1984-08-03
K832044 — SHILEY MULTIPRO CATHETER Shiley, Inc. · 1983-09-29
K832023 — EMBOLECTOMY CATHETER Bionomy, Inc. · 1983-08-31
K820646 — ATRAC TM MULTIPURPOSE BALLOON CATHETER Atrium Medical Corp. · 1982-03-25
K812640 — URE SIL EMBOLECTOMY/THROMBECTOMY CATH Uresil Corp. · 1981-10-02
K801650 — DESERET EMBOLECTOMY/THROMBECTOMY CATH. Deseret Medical, Inc. · 1980-08-04
K790838 — ARTERIAL EMBOLECTOMY CATHETER (MODIFIED) Shiley, Inc. · 1979-06-11
K780762 — EMBOLECTOMY CATHETER, EXTEND. SHELF LIFE Shiley, Inc. · 1978-05-26
K780244 — CATHETERS, ARTERIAL EMBOLECTOMY Extracorporeal Medical Specialities, Inc. · 1978-04-13
K770714 — CATHETER, ARTERIAL EMBOLECTOMY Mallinckrodt Critical Care · 1977-04-27
K770569 — CATHETER, EMBOLECTOMY, UMI Universal Medical Instrument Corp. · 1977-04-05
K761031 — ELECATH ARTERIAL EMBOLECTOMY CATHETER Electro-Catheter Corp. · 1976-12-13

Data sourced from openFDA. This site is unofficial and independent of the FDA.