Catheter, Embolectomy

FDA product code DXE · 73 cleared devices

Class 2 Cardiovascular

Regulation: 21 CFR 870.5150
Review panel: CV
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-12-13 – 2024-08-28

DXE 2024-08-28

Fogarty Thru-Lumen Embolectomy Catheter

Applicant Edwards Lifesciences, LLC

K number K240078

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DXE 2024-07-02

Fogarty Fortis Arterial Embolectomy Catheter

Applicant Edwards Lifesciences

K number K241330

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DXE 2024-05-22

Fogarty Arterial Embolectomy Catheter with Gate Valve

Applicant Edwards Lifesciences

K number K233820

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DXE 2024-05-22

Fogarty Venous Thrombectomy Catheters

Applicant Edwards Lifesciences, LLC

K number K233819

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DXE 2024-05-20

Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters

Applicant Edwards Lifesciences

K number K233619

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DXE 2022-01-27

Merlin Aspiration System

Applicant Mivi Neurovascular, Inc.

K number K213771

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DXE 2021-09-07

Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter

Applicant Applied Medical Resources Corporation

K number K202049

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DXE 2020-06-12

Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe

Applicant Edwards Lifesciences, LLC

K number K193379

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DXE 2017-07-27

Bunegin-Albin Air Aspiration Set

Applicant Cook Incorporated

K number K163031

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DXE 2017-07-11

Needle's Eye Snare Retrieval Set - 54cm

Applicant Cook Incorporated

K number K163353

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DXE 2010-07-12

PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CM

Applicant Hotspur Technologies

K number K100842

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DXE 2010-07-12

EMBO PLUS EMBOLECTOMY CATHETER

Applicant Hotspur Technologies

K number K100840

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DXE 2008-06-27

MEDTRONIC EXPORT AP CATHETER

Applicant Medtronic Vascular

K number K081573

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DXE 2003-01-14

OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302

Applicant LeMaitre Vascular, Inc.

K number K022145

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DXE 2002-05-08

MODIFICATION TO ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER

Applicant Atrium Medical Corp.

K number K020634

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DXE 2002-01-24

MULTI-SNARE SET

Applicant Pfm Produkte Fur Die Medizin AG

K number K011783

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DXE 2001-04-26

ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER

Applicant Atrium Medical Corp.

K number K002627

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DXE 2000-03-08

LEMAITRE IRRIGATION CATHETER

Applicant Vascutech, Inc.

K number K992933

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DXE 2000-03-01

LEMAITRE VENOUS THROMBECTOMY CATHETER

Applicant Vascutech, Inc.

K number K992934

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DXE 2000-02-22

LEMAITRE BALLOON CATHETER WITH IRRIGATION

Applicant Vascutech, Inc.

K number K992940

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DXE 1999-12-09

LEMAITRE EMBOLECTOMY CATHETER

Applicant Vascutech, Inc.

K number K992368

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DXE 1998-09-04

BIOSENSORS EMBOLECTOMY CATHETER

Applicant Sunscope Intl., Inc.

K number K973477

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DXE 1998-08-31

ARROW 5FX60CM BALLOON EMBOLECTOMY CATHETER, MODEL # EM-56025

Applicant Arrow Intl., Inc.

K number K982141

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DXE 1998-03-17

DCAT EMBOLECTOMY CATHETER SYSTEM

Applicant AngioDynamics, Inc.

K number K971314

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DXE 1998-03-06

AMPLATZ GOOSE NECK SNARE KIT/ CATHETER

Applicant Microvena Corp.

K number K972511

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DXE 1998-02-19

LATIS GRAFT CLEANING CATHETER

Applicant Applied Medical Resources

K number K973465

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DXE 1998-02-13

EMBOLECTOMY, IRRIGATION - OCCLUSION BALLOON CATHETER BY J-LLOYD MEDICAL, INC.

Applicant J-Lloyd Medical, Inc.

K number K974335

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DXE 1998-01-13

SINGLE LUMEN EMBOLECTOMY CATHETER

Applicant American Biomed, Inc.

K number K972572

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DXE 1997-11-19

LMI IRRIGATION CATHETER (IGR)

Applicant Lucas Medical, Inc.

K number K972623

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DXE 1997-07-01

LMI THROMBECTOMY CATHETER

Applicant Lucas Medical, Inc.

K number K970657

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DXE 1997-03-28

DUAL LUMEN EMBOLECTOMY CATHETER

Applicant Applied Medical Resources

K number K970762

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DXE 1997-01-13

VERSA-CATH ARTERIAL CATHETER

Applicant Ideas For Medicine, Inc.

K number K961883

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DXE 1996-12-27

NEEDLE'S EYE SNARE

Applicant Cook Pacemaker Corp.

K number K961992

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DXE 1996-09-19

VASO-SAFE ARTERIAL EMBOLECTOMY CATHETE

Applicant Ideas For Medicine, Inc.

K number K961716

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DXE 1996-04-11

LMI ARTERIAL EMBOLECTOMY CATHETER

Applicant Lucas Medical, Inc.

K number K954760

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DXE 1996-03-11

LMI OCCLUSION CATHETER

Applicant Lucas Medical, Inc.

K number K955125

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DXE 1995-05-15

AVD INTIMAX THROMBECTOMY CATHETER

Applicant Applied Medical Resources

K number K950586

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DXE 1994-07-25

ARTERIAL EMBOLECTOMY

Applicant J-Lloyd Medical, Inc.

K number K935405

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DXE 1993-03-04

WELTER SNARE RETRIEVER

Applicant Cook, Inc.

K number K920823

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DXE 1993-02-26

J-LLOYD ARTERIAL EMBOLECTOMY CATHETER

Applicant J-Lloyd Medical, Inc.

K number K920871

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DXE 1992-03-16

DUAL BALLOON EMBOLECTOMY CATHETER

Applicant Ideal Medical, Inc.

K number K914880

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DXE 1991-04-26

INTIMAX THROMBECTOMY CATHETER

Applicant Applied Vascular Devices, Inc.

K number K910372

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DXE 1991-02-25

CATHLAB SILICONE ARTERIAL EMBOLECTOMY CATHETER

Applicant Cathlab Corp.

K number K905139

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DXE 1991-02-25

EMBOLECTOMY CATHETER

Applicant Clincal Instruments Corp.

K number K902327

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DXE 1990-12-03

AMPLATZ GOOSE-NECK SNARE

Applicant Microvena Corp.

K number K901502

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DXE 1990-10-19

ARTERIAL EMBOLECTOMY CATHETER

Applicant Applied Vascular Devices, Inc.

K number K901627

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DXE 1990-07-17

ARTERIAL EMBOLECTOMY CATHETER

Applicant Impra, Inc.

K number K900311

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DXE 1990-07-06

FOGARTY ARTERIAL EMBOLECTOMY II CATHETER

Applicant Baxter Healthcare Corp

K number K901625

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DXE 1990-03-14

3F AND 4F IRRIGATION EMBOLECTOMY CATHETERS

Applicant Cathlab Corp.

K number K897184

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DXE 1989-12-07

CATHETER, CARDIOVASCULAR, BALLOON TYPE

Applicant Wb Intl., Inc.

K number K883852

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DXE 1989-10-12

REVISED LABELING FOR ARTERIAL EMBOLECTOMY CATHETER

Applicant Shiley, Inc.

K number K894681

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DXE 1989-09-18

TRI-LUMEN INTRA VASCULAR BALLOON CATHETER

Applicant Ideal Medical, Inc.

K number K891021

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DXE 1989-08-01

SILICONE BI-LUMEN IRRIGATION EMBOLECTOMY CATH.

Applicant Cathlab Corp.

K number K893680

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DXE 1989-07-20

FOGARTY(R) THRU-LUMEN EMBOLECTOMY CATHETER

Applicant Baxter Healthcare Corp

K number K892410

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DXE 1988-06-15

EMBOLECTOMY CATHETER(MODIFIED)

Applicant Cathlab Corp.

K number K881455

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DXE 1987-08-12

CHANGE OF CATHETER BODY MATERIAL (RADIO-OPAQUE NY)

Applicant Ideas For Medicine, Inc.

K number K872485

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DXE 1987-01-06

SHEAR FORCE GAUGE

Applicant American Edwards Laboratories

K number K864330

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DXE 1987-01-06

PRUITT EMBOLECTOMY/IRRIGATION CATHETER (MODIFIED)

Applicant Ideas For Medicine, Inc.

K number K864062

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DXE 1987-01-02

EMBOLECTOMY/THROMBECTOMY BALLOON CATHETER

Applicant Uresil Corp.

K number K864007

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DXE 1986-01-15

NOVA ARTERIAL EMBOLECTOMY CATHETER

Applicant Nova Medical Specialties

K number K853625

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DXE 1985-06-19

POLYMED LAB ARTERIAL EMBOLECTOMY CATHETER

Applicant Polymed Laboratories

K number K850015

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DXE 1984-08-03

ARTERIAL EMBOLECTOMY CATHETER

Applicant Shiley, Inc.

K number K840198

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DXE 1983-09-29

SHILEY MULTIPRO CATHETER

Applicant Shiley, Inc.

K number K832044

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DXE 1983-08-31

EMBOLECTOMY CATHETER

Applicant Bionomy, Inc.

K number K832023

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DXE 1982-03-25

ATRAC TM MULTIPURPOSE BALLOON CATHETER

Applicant Atrium Medical Corp.

K number K820646

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DXE 1981-10-02

URE SIL EMBOLECTOMY/THROMBECTOMY CATH

Applicant Uresil Corp.

K number K812640

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DXE 1980-08-04

DESERET EMBOLECTOMY/THROMBECTOMY CATH.

Applicant Deseret Medical, Inc.

K number K801650

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DXE 1979-06-11

ARTERIAL EMBOLECTOMY CATHETER (MODIFIED)

Applicant Shiley, Inc.

K number K790838

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DXE 1978-05-26

EMBOLECTOMY CATHETER, EXTEND. SHELF LIFE

Applicant Shiley, Inc.

K number K780762

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DXE 1978-04-13

CATHETERS, ARTERIAL EMBOLECTOMY

Applicant Extracorporeal Medical Specialities, Inc.

K number K780244

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DXE 1977-04-27

CATHETER, ARTERIAL EMBOLECTOMY

Applicant Mallinckrodt Critical Care

K number K770714

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DXE 1977-04-05

CATHETER, EMBOLECTOMY, UMI

Applicant Universal Medical Instrument Corp.

K number K770569

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DXE 1976-12-13

ELECATH ARTERIAL EMBOLECTOMY CATHETER

Applicant Electro-Catheter Corp.

K number K761031

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