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)
Top companies in DXE
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 7, 2026 | LeMaitre Vascular, Inc. TufTex Over-the-Wire Embolectomy Catheter;
Catalog Number: E1651-88; Open, Classified |
DXE | K022145 |
| Jun 23, 2026 | PFM MEDICAL INC. Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310 Open, Classified |
DXE | K011783 |
| May 12, 2025 | LeMaitre 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 |
DXE | K022145 |
| May 15, 2024 | LeMaitre Vascular, Inc. Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies. Open, Classified |
DXE | K910372 |
| Nov 6, 2023 | Edwards Lifesciences, LLC Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35 Open, Classified |
DXE | K892410 |
| Nov 11, 2022 | LeMaitre 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 |
DXE | K992368 |
| Oct 28, 2022 | Edwards Lifesciences, LLC Fogarty Biliary Balloon Probes Model Number:
410235FP
410405FP
410236FP Open, Classified |
DXE | K193379 |
| Oct 28, 2022 | Edwards 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 |
DXE | K193379 |
| Nov 18, 2021 | Arrow 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 |
DXE | K011056 |
| Nov 18, 2021 | Arrow 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 |
DXE | K011056 |
| Nov 18, 2021 | Arrow 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 |
DXE | K011056 |
| Nov 18, 2021 | Arrow 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 |
DXE | K011056 |
| May 7, 2020 | Applied 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 |
DXE | K973465 |
| May 7, 2020 | Applied 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 |
DXE | K970762 |
| May 7, 2020 | Applied 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 |
DXE | K970762 |
| Apr 1, 2020 | LeMaitre 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 |
DXE | K022145 |
| Mar 23, 2020 | INARI MEDICAL Triever20 Aspiration Guide Catheter a component of FlowTriever Retrieval/ Aspiration System, UDI: 00850291007079 Terminated |
DXE | K182233 |
| Jul 6, 2017 | Edwards 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 |
DXE | K901625 |
| Jul 7, 2016 | Arrow International Inc Walrus Arterial Embolectomy Catheter
The arterial embolectomy catheter is intended for use in removing arterial emboli. Terminated |
DXE | K902327 |
| Apr 18, 2016 | Boston 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 |
DXE | K101354 |
| Dec 4, 2015 | LeMaitre 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 |
DXE | K992368 |
| Dec 4, 2015 | LeMaitre 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 |
DXE | K992368 |
| Dec 4, 2015 | LeMaitre 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 |
DXE | K992368 |
| Dec 4, 2015 | LeMaitre 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 |
DXE | K992368 |
| Dec 4, 2015 | LeMaitre 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 |
DXE | K992368 |
| Dec 4, 2015 | LeMaitre 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 |
DXE | K022145 |
| Dec 4, 2015 | LeMaitre 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 |
DXE | K022145 |
| Dec 4, 2015 | LeMaitre 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 |
DXE | K022145 |
| Dec 4, 2015 | LeMaitre 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 |
DXE | K022145 |
| Dec 4, 2015 | LeMaitre 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 |
DXE | K022145 |
| Dec 4, 2015 | LeMaitre 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 |
DXE | K022145 |
| Dec 4, 2015 | LeMaitre Vascular, Inc. LeMaitre Over-the-Wire Embolectomy Catheter 3F, 80cm, Model 1651-38.
Indicated for the removal of arterial emboli and thrombi. Terminated |
DXE | K022145 |
| Dec 4, 2015 | LeMaitre 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 |
DXE | K022145 |
| Aug 13, 2015 | Boston 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 |
DXE | K133629 |
| Aug 13, 2015 | Boston 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 |
DXE | K113363 |
| Aug 13, 2015 | Boston 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 |
DXE | K111182 |
| Aug 13, 2015 | Boston Scientific Corporation AngioJet Spiroflex Thrombectomy Set: Peripheral - UPN 106553-004, Catalog No.106553, Sterilized Using Ethylene Oxide. For breaking apart and removing t Terminated |
DXE | K072769 |
| Jun 7, 2013 | Invatec 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 |
DXE | K050276 K051917 |
| Sep 25, 2012 | Applied 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 |
DXE | K901627 |
| Aug 4, 2011 | Vascular 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 |
DXE | K103405 |
| Aug 9, 2010 | Spectranetics Corporation Spectranetics Corporation, QuickCat Extraction Catheter, REF 60090-01, Sterile R, Working Length 145cm, for embolus and thrombus removal from arterial vessels. Terminated |
DXE | K060092 K073519 |
| Dec 17, 2009 | Vascular 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 |
DXE | K051193 |
| Jun 25, 2009 | Arrow 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 |
DXE | K902327 |
| Jun 25, 2009 | Arrow 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 |
DXE | K902327 |
| Jun 25, 2009 | Arrow 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 |
DXE | K902327 |
| Jun 24, 2009 | Arrow International Inc Arrow OTW Percutaneous Thrombolytic Device (PTD) for fistulae and dialysis grafts Terminated |
DXE | K011056 |
| Aug 10, 2007 | Possis 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 |
DXE | K050794 |
| Jul 11, 2007 | Ev3, 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 |
DXE | K972511 |
| Jun 21, 2007 | Possis 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 |
DXE | K042874 |
| Jun 2, 2006 | Ev3, 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 |
DXE | K901502 |
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