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

DateFirm and productCodeLinked 510(k)
Oct 7, 2026LeMaitre Vascular, Inc.
TufTex Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88;
Open, Classified
DXEK022145
Jun 23, 2026PFM MEDICAL INC.
Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310
Open, Classified
DXEK011783
May 12, 2025LeMaitre Vascular, Inc.
TufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651-38, 1651-44, 1651-48, 1651-58, 1651-64, 1651-68, 1651-78, 1651-84, 1651-88, E1651-34, E1651-38, E1651-44, E1651-48, E1651-
Open, Classified
DXEK022145
May 15, 2024LeMaitre Vascular, Inc.
Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.
Open, Classified
DXEK910372
Nov 6, 2023Edwards Lifesciences, LLC
Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35
Open, Classified
DXEK892410
Nov 11, 2022LeMaitre Vascular, Inc.
TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It is inserted using a guidewire or introducer. The devices affected by this recall are 3F and
Open, Classified
DXEK992368
Oct 28, 2022Edwards Lifesciences, LLC
Fogarty Biliary Balloon Probes Model Number: 410235FP 410405FP 410236FP
Open, Classified
DXEK193379
Oct 28, 2022Edwards Lifesciences, LLC
Fogarty Arterial Embolectomy Catheters Model Number: 120602FP 120403FP 120803FP 120404FP 120804FP 120805FP 120806FP 120807FP Fogarty Arterial Embolectomy Catheter with Stylet Model Number: 120403FSP
Open, Classified
DXEK193379
Nov 18, 2021Arrow International Inc
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-WC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the
Terminated
DXEK011056
Nov 18, 2021Arrow International Inc
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-W The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the A
Terminated
DXEK011056
Nov 18, 2021Arrow International Inc
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-HFWC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with th
Terminated
DXEK011056
Nov 18, 2021Arrow International Inc
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-12709-WC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the
Terminated
DXEK011056
May 7, 2020Applied Medical Resources Corp
Applied Medical Dual Lumen Graft Cleaning Catheter & 1cc SYRINGE Nonpyrogenic, REF: A4GW6, 5F X 60cm, 9mm, Sterile EO, CE, UDI: (01)00607915111175
Terminated
DXEK973465
May 7, 2020Applied Medical Resources Corp
Bard Embolectomy Catheter & 1 ml SYRINGE, REF numbers/UDI: CE0340DR/(01)H699CE0340DR10R; CE0380DR/(01)H699CE0380DR10V; CE0440DR/(01)H699CE0440DR10S; CE0480DR/(01)H699CE0480DR10W; CE0540DR/(01)H69
Terminated
DXEK970762
May 7, 2020Applied Medical Resources Corp
Python Embolectomy Catheters, Sterile EO, CE, Ref numbers/UDI: A4E01/(01)00607915113407; A4E02/(01)00607915113414; A4E03/(01)00607915113421; A4E04/(01)00607915113438; A4E05/(01)00607915113445; A4
Terminated
DXEK970762
Apr 1, 2020LeMaitre Vascular, Inc.
LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88, e1651-88. The LeMaitre Over the Wire Embolectomy Catheter is indicated for use in the removal of emboli and
Open, Classified
DXEK022145
Mar 23, 2020INARI MEDICAL
Triever20 Aspiration Guide Catheter a component of FlowTriever Retrieval/ Aspiration System, UDI: 00850291007079
Terminated
DXEK182233
Jul 6, 2017Edwards Lifesciences, LLC
Fogarty Adherent Clot Catheter Model Numbers 1408010 and 140806 Product Usage: The Fogarty adherent clot catheters are designed to effectively remove clot material in the peripheral vasculature. T
Terminated
DXEK901625
Jul 7, 2016Arrow International Inc
Walrus Arterial Embolectomy Catheter The arterial embolectomy catheter is intended for use in removing arterial emboli.
Terminated
DXEK902327
Apr 18, 2016Boston Scientific Corporation
Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the per
Terminated
DXEK101354
Dec 4, 2015LeMaitre Vascular, Inc.
LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 2F, 60 cm, Model e1801-26. Indicated for the removal of arterial emboli and thrombi.
Terminated
DXEK992368
Dec 4, 2015LeMaitre Vascular, Inc.
LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 6F, 80 cm, Model 1601-68. Indicated for the removal of arterial emboli and thrombi.
Terminated
DXEK992368
Dec 4, 2015LeMaitre Vascular, Inc.
LeMaitre Single Lumen Embolectomy Catheter 5F, 80 cm, Model 1601-58 and e1601-58. Indicated for the removal of arterial emboli and thrombi.
Terminated
DXEK992368
Dec 4, 2015LeMaitre Vascular, Inc.
LeMaitre Single Lumen Embolectomy Catheter 4F, 80 cm, Model 1601-48 and e1601-48. Indicated for the removal of arterial emboli and thrombi.
Terminated
DXEK992368
Dec 4, 2015LeMaitre Vascular, Inc.
LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm, Model 1601-38 and e1601-38. Indicated for the removal of arterial emboli and thrombi.
Terminated
DXEK992368
Dec 4, 2015LeMaitre Vascular, Inc.
LeMaitre Over-the-Wire Embolectomy Catheter 6F, 80 cm, Model e-1651-68. Indicated for the removal of arterial emboli and thrombi.
Terminated
DXEK022145
Dec 4, 2015LeMaitre Vascular, Inc.
LeMaitre Over-the-Wire Embolectomy Catheter 6F, 40 cm, Model e-1651-64. Indicated for the removal of arterial emboli and thrombi.
Terminated
DXEK022145
Dec 4, 2015LeMaitre Vascular, Inc.
LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 40 cm, Model e1651-84. Indicated for the removal of arterial emboli and thrombi.
Terminated
DXEK022145
Dec 4, 2015LeMaitre Vascular, Inc.
LeMaitre Over-the-Wire Embolectomy Catheter 7F, 80cm, Model 1654-78 and e1654-78. Indicated for the removal of arterial emboli and thrombi.
Terminated
DXEK022145
Dec 4, 2015LeMaitre Vascular, Inc.
LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 80cm, Model 1651-88 and e1654-88. Indicated for the removal of arterial emboli and thrombi.
Terminated
DXEK022145
Dec 4, 2015LeMaitre Vascular, Inc.
LeMaitre Over-the-Wire Embolectomy Catheter 4F, 80cm, Model 1651-48 and e1654-48. Indicated for the removal of arterial emboli and thrombi.
Terminated
DXEK022145
Dec 4, 2015LeMaitre Vascular, Inc.
LeMaitre Over-the-Wire Embolectomy Catheter 3F, 80cm, Model 1651-38. Indicated for the removal of arterial emboli and thrombi.
Terminated
DXEK022145
Dec 4, 2015LeMaitre Vascular, Inc.
LeMaitre Over-the-Wire Embolectomy Catheter 3F, 40cm, Model 1651-34 and e1651-34. Indicated for the removal of arterial emboli and thrombi.
Terminated
DXEK022145
Aug 13, 2015Boston Scientific Corporation
AngioJet AVX Thrombectomy Set: UPN 105039-001, Catalog No.105039, Sterilized Using Ethylene Oxide. For breaking apart and removing thrombus from vascul
Terminated
DXEK133629
Aug 13, 2015Boston Scientific Corporation
AngioJet SOLENT Dista Thrombectomy Set: UPN 111303-001, Catalog No. 111303, Sterilized Using Ethylene Oxide. For breaking apart and removing thrombus f
Terminated
DXEK113363
Aug 13, 2015Boston Scientific Corporation
AngioJet SOLENT Omni Thrombectomy Set: UPN 109681-004 & 109681-001, Catalog No 109681, Sterilized. For breaking apart and removing thrombus from vascu
Terminated
DXEK111182
Aug 13, 2015Boston Scientific Corporation
AngioJet Spiroflex Thrombectomy Set: Peripheral - UPN 106553-004, Catalog No.106553, Sterilized Using Ethylene Oxide. For breaking apart and removing t
Terminated
DXEK072769
Jun 7, 2013Invatec Llc
lnvatec SpA brand Diver C.E., Model/Catalog Numbers: DVR010014145, DVR011014145, Product is manufactured by lnvatec SpA, Roncadelle, Italy, and distributed by Invatec, Inc., Bethlehem, PA and by Me
Terminated
DXEK050276
K051917
Sep 25, 2012Applied Medical Resources Corp
Embolectomy Catheters (Models A44XX, A4FXX, CE0XXXST, and CE0XXX): Model Numbers & Description: A4402, 3F-40CM, SYNTEL RT-EMB; A4403, 3F-80CM, SYNTEL RT-EMB; A4404, 4F-40CM, SYNTEL RT-EMB; A4405, 4F-
Terminated
DXEK901627
Aug 4, 2011Vascular Solutions, Inc.
Vascular Solutions, Pronto V4, Extraction Catheter, Sterilized using ethylene oxide, Rx Only. The following sizes/model numbers are affected: 5.5F( 4005), 6F(4006, 7F(4007, 8F(4008) are involved in t
Terminated
DXEK103405
Aug 9, 2010Spectranetics Corporation
Spectranetics Corporation, QuickCat Extraction Catheter, REF 60090-01, Sterile R, Working Length 145cm, for embolus and thrombus removal from arterial vessels.
Terminated
DXEK060092
K073519
Dec 17, 2009Vascular Solutions, Inc.
Vascular Solutions Pronto-Short Extraction Catheter. Model 5030. The PRONTO-Short Extraction catheter is a dual lumen, over-the-wire (OTW) catheter with related accessories. The catheter is designed
Terminated
DXEK051193
Jun 25, 2009Arrow International Inc
Arrow Embolectomy Catheters: 4 French, 2 Lumen x 40cm, Product Number: W01798, Single use, Latex Free, Rx only, Arrow International, 2400 Bernville Road, Reading, PA 19605. The arterial embolectomy c
Terminated
DXEK902327
Jun 25, 2009Arrow International Inc
Arrow Embolectomy Catheters: 5 French, 2 Lumen x 80cm, Product Number: W01801, Single use, Latex Free, Rx only, Arrow International, 2400 Bernville Road, Reading, PA 19605. The arterial embolectomy c
Terminated
DXEK902327
Jun 25, 2009Arrow International Inc
Arrow Embolectomy Catheters: 5 French, 2 Lumen x 40cm, Product Number: W01800, Single use, Latex Free, Rx only, Arrow International, 2400 Bernville Road, Reading, PA 19605. The arterial embolectomy c
Terminated
DXEK902327
Jun 24, 2009Arrow International Inc
Arrow OTW Percutaneous Thrombolytic Device (PTD) for fistulae and dialysis grafts
Terminated
DXEK011056
Aug 10, 2007Possis Medical, Inc
Possis AngioJet XVG Thrombectomy Sets, Model/Order # 105042-001, Sterilized with Ethylene Oxide, Possis Medical, Inc., 9055 Evergreen Boulevard NW, Minneapolis, MN 55433-8003. (These sets are used wit
Terminated
DXEK050794
Jul 11, 2007Ev3, Inc
Amplatz Goose Neck Snare Kit, 6 Fr, Lot 1650307, REF: GN3000, Use By 2009-09-01, Sterile EO ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA THE ENDOVASCULAR COMPANY. The Snare Kit contains
Terminated
DXEK972511
Jun 21, 2007Possis Medical, Inc
Angiojet XMI Rapid Exchange, catheters, 135 cm, 4 F, Single Use Only, Sterilized with Ethylene Oxide, POSSIS MEDICAL, INC. 9055 Evergreen Boulevard NW Minneapolis, MN 55433-8003 USA-- (XMI - Rapid E
Terminated
DXEK042874
Jun 2, 2006Ev3, Inc
Amplatz Goose Neck Microsnare Kit, Model SK400 (175 cm length x 4mm loop snare x .018'',0.46mm) and SK701 (200 cm length x 7mm loop snare x 0.18'' x 0.46mm) ev3, 4600 Nathan Lane North, Plymouth, Min
Terminated
DXEK901502

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