Atlas FDA

DXE

74 FDA 510(k) clearances · Product code

138 daysmedian time to decision
269 days90th percentile
74clearances measured

FDA profile

Official device name
Catheter, Embolectomy
Device class
Class II (moderate risk)
Regulation
21 CFR 870.5150
Medical specialty
Cardiovascular
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 333 · 2022: 463 · 2023: 436 · 2024: 377 · 2025: 310 · 2026: 293
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Fogarty Thru-Lumen Embolectomy Catheter (K240078)Edwards Lifesciences, LLC2024-08-28
Fogarty Fortis Arterial Embolectomy Catheter (K241330)Edwards Lifesciences2024-07-02
Fogarty Arterial Embolectomy Catheter with Gate Valve (K233820)Edwards Lifesciences2024-05-22
Fogarty Venous Thrombectomy Catheters (K233819)Edwards Lifesciences, LLC2024-05-22
Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters (K233619)Edwards Lifesciences2024-05-20
Merlin Aspiration System (K213771)Mivi Neurovascular, Inc.2022-01-27
Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter (K202049)Applied Medical Resources Corporation2021-09-07
Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe (K193379)Edwards Lifesciences, LLC2020-06-12
Bunegin-Albin Air Aspiration Set (K163031)Cook Incorporated2017-07-27
Needle's Eye Snare Retrieval Set - 54cm (K163353)Cook Incorporated2017-07-11
Export Advance Aspiration Catheter (K152335)Medtronic, Inc.2015-09-18
EMBO PLUS EMBOLECTOMY CATHETER (K100840)Hotspur Technologies2010-07-12
PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CM (K100842)Hotspur Technologies2010-07-12
MEDTRONIC EXPORT AP CATHETER (K081573)Medtronic Vascular2008-06-27
OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302 (K022145)LeMaitre Vascular, Inc.2003-01-14
MODIFICATION TO ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER (K020634)Atrium Medical Corp.2002-05-08
MULTI-SNARE SET (K011783)Pfm Produkte Fur Die Medizin AG2002-01-24
ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER (K002627)Atrium Medical Corp.2001-04-26
LEMAITRE IRRIGATION CATHETER (K992933)Vascutech, Inc.2000-03-08
LEMAITRE VENOUS THROMBECTOMY CATHETER (K992934)Vascutech, Inc.2000-03-01
LEMAITRE BALLOON CATHETER WITH IRRIGATION (K992940)Vascutech, Inc.2000-02-22
LEMAITRE EMBOLECTOMY CATHETER (K992368)Vascutech, Inc.1999-12-09
BIOSENSORS EMBOLECTOMY CATHETER (K973477)Sunscope Intl., Inc.1998-09-04
ARROW 5FX60CM BALLOON EMBOLECTOMY CATHETER, MODEL # EM-56025 (K982141)Arrow Intl., Inc.1998-08-31
DCAT EMBOLECTOMY CATHETER SYSTEM (K971314)AngioDynamics, Inc.1998-03-17
AMPLATZ GOOSE NECK SNARE KIT/ CATHETER (K972511)Microvena Corp.1998-03-06
LATIS GRAFT CLEANING CATHETER (K973465)Applied Medical Resources1998-02-19
EMBOLECTOMY, IRRIGATION - OCCLUSION BALLOON CATHETER BY J-LLOYD MEDICAL, INC. (K974335)J-Lloyd Medical, Inc.1998-02-13
SINGLE LUMEN EMBOLECTOMY CATHETER (K972572)American Biomed, Inc.1998-01-13
LMI IRRIGATION CATHETER (IGR) (K972623)Lucas Medical, Inc.1997-11-19
LMI THROMBECTOMY CATHETER (K970657)Lucas Medical, Inc.1997-07-01
DUAL LUMEN EMBOLECTOMY CATHETER (K970762)Applied Medical Resources1997-03-28
VERSA-CATH ARTERIAL CATHETER (K961883)Ideas For Medicine, Inc.1997-01-13
NEEDLE'S EYE SNARE (K961992)Cook Pacemaker Corp.1996-12-27
VASO-SAFE ARTERIAL EMBOLECTOMY CATHETE (K961716)Ideas For Medicine, Inc.1996-09-19
LMI ARTERIAL EMBOLECTOMY CATHETER (K954760)Lucas Medical, Inc.1996-04-11
LMI OCCLUSION CATHETER (K955125)Lucas Medical, Inc.1996-03-11
AVD INTIMAX THROMBECTOMY CATHETER (K950586)Applied Medical Resources1995-05-15
ARTERIAL EMBOLECTOMY (K935405)J-Lloyd Medical, Inc.1994-07-25
WELTER SNARE RETRIEVER (K920823)Cook, Inc.1993-03-04
J-LLOYD ARTERIAL EMBOLECTOMY CATHETER (K920871)J-Lloyd Medical, Inc.1993-02-26
DUAL BALLOON EMBOLECTOMY CATHETER (K914880)Ideal Medical, Inc.1992-03-16
INTIMAX THROMBECTOMY CATHETER (K910372)Applied Vascular Devices, Inc.1991-04-26
CATHLAB SILICONE ARTERIAL EMBOLECTOMY CATHETER (K905139)Cathlab Corp.1991-02-25
EMBOLECTOMY CATHETER (K902327)Clincal Instruments Corp.1991-02-25
AMPLATZ GOOSE-NECK SNARE (K901502)Microvena Corp.1990-12-03
ARTERIAL EMBOLECTOMY CATHETER (K901627)Applied Vascular Devices, Inc.1990-10-19
ARTERIAL EMBOLECTOMY CATHETER (K900311)Impra, Inc.1990-07-17
FOGARTY ARTERIAL EMBOLECTOMY II CATHETER (K901625)Baxter Healthcare Corp1990-07-06
3F AND 4F IRRIGATION EMBOLECTOMY CATHETERS (K897184)Cathlab Corp.1990-03-14
CATHETER, CARDIOVASCULAR, BALLOON TYPE (K883852)Wb Intl., Inc.1989-12-07
REVISED LABELING FOR ARTERIAL EMBOLECTOMY CATHETER (K894681)Shiley, Inc.1989-10-12
TRI-LUMEN INTRA VASCULAR BALLOON CATHETER (K891021)Ideal Medical, Inc.1989-09-18
SILICONE BI-LUMEN IRRIGATION EMBOLECTOMY CATH. (K893680)Cathlab Corp.1989-08-01
FOGARTY(R) THRU-LUMEN EMBOLECTOMY CATHETER (K892410)Baxter Healthcare Corp1989-07-20
EMBOLECTOMY CATHETER(MODIFIED) (K881455)Cathlab Corp.1988-06-15
CHANGE OF CATHETER BODY MATERIAL (RADIO-OPAQUE NY) (K872485)Ideas For Medicine, Inc.1987-08-12
SHEAR FORCE GAUGE (K864330)American Edwards Laboratories1987-01-06
PRUITT EMBOLECTOMY/IRRIGATION CATHETER (MODIFIED) (K864062)Ideas For Medicine, Inc.1987-01-06
EMBOLECTOMY/THROMBECTOMY BALLOON CATHETER (K864007)Uresil Corp.1987-01-02
NOVA ARTERIAL EMBOLECTOMY CATHETER (K853625)Nova Medical Specialties1986-01-15
POLYMED LAB ARTERIAL EMBOLECTOMY CATHETER (K850015)Polymed Laboratories1985-06-19
ARTERIAL EMBOLECTOMY CATHETER (K840198)Shiley, Inc.1984-08-03
SHILEY MULTIPRO CATHETER (K832044)Shiley, Inc.1983-09-29
EMBOLECTOMY CATHETER (K832023)Bionomy, Inc.1983-08-31
ATRAC TM MULTIPURPOSE BALLOON CATHETER (K820646)Atrium Medical Corp.1982-03-25
URE SIL EMBOLECTOMY/THROMBECTOMY CATH (K812640)Uresil Corp.1981-10-02
DESERET EMBOLECTOMY/THROMBECTOMY CATH. (K801650)Deseret Medical, Inc.1980-08-04
ARTERIAL EMBOLECTOMY CATHETER (MODIFIED) (K790838)Shiley, Inc.1979-06-11
EMBOLECTOMY CATHETER, EXTEND. SHELF LIFE (K780762)Shiley, Inc.1978-05-26
CATHETERS, ARTERIAL EMBOLECTOMY (K780244)Extracorporeal Medical Specialities, Inc.1978-04-13
CATHETER, ARTERIAL EMBOLECTOMY (K770714)Mallinckrodt Critical Care1977-04-27
CATHETER, EMBOLECTOMY, UMI (K770569)Universal Medical Instrument Corp.1977-04-05
ELECATH ARTERIAL EMBOLECTOMY CATHETER (K761031)Electro-Catheter Corp.1976-12-13

Track DXE automatically

Every clearance here is in the API, with alerts when new ones post.