Product Code: DXE FDA class 2 21 CFR 870.5150

Catheter, Embolectomy

Cardiovascular

The Embolectomy Catheter is a cardiovascular interventional device used to retrieve blood clots from occluded arteries or veins by advancing a balloon catheter past the clot, inflating the balloon, and withdrawing it to extract the embolus and restore vascular patency. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DXE and it is regulated under 21 CFR 870.5150 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: DXE
Device Class: FDA class 2
Regulation Number: 870.5150
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 74 510(k) clearances via K numbers.

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