Company ยท US
LeMaitre Vascular, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2022. Name variants (Inc, Corp, punctuation) are merged.
35510(k) clearances (0 in 12 months)
85recalls (2 in 12 months)
66recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DXE | Catheter, Embolectomy | 24 |
| MAL | Graft, Vascular, Synthetic/Biologic Composite | 19 |
| DQO | Catheter, Intravascular, Diagnostic | 12 |
| MJN | Catheter, Intravascular Occluding, Temporary | 12 |
| MGZ | Valvulotome | 10 |
| FZP | Clip, Implantable | 9 |
| DQY | Catheter, Percutaneous | 5 |
| FTY | Tape, Measuring, Rulers And Calipers | 4 |
| LXA | Tissue Graft Of 6mm And Greater | 4 |
| HBT | Applier, Hemostatic Clip | 3 |
| DQT | Occluder, Catheter Tip | 2 |
| DWQ | Stripper, Vein, External | 2 |
| DXT | Injector And Syringe, Angiographic | 2 |
| KFX | Assembly, Thigh/Knee/Shank/Ankle/Foot, External | 2 |
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 2 |
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | 1 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 1 |
| DWX | Stripper, Artery, Intraluminal | 1 |
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | 1 |
| DYG | Catheter, Flow Directed | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 31, 2022 | K212894 | PhasTIPP LeMaitre Vascular, Inc. | DWQ |
| Feb 13, 2020 | K190882 | XenoSure Biologic Patch Lemaitre Vascular | PSQ |
| Oct 30, 2019 | K190267 | EZE SIT Valvulotome Lemaitre Vascular | MGZ |
| Jun 13, 2019 | K183513 | XenoSure Dura Biologic Patch LeMaitre Vascular, Inc. | GXQ |
| Nov 16, 2018 | K182916 | Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr Lemaitre Vascular | MJN |
| Mar 8, 2018 | K173323 | AnastoClip GC Closure System LeMaitre Vascular, Inc. | FZP |
| Jan 21, 2016 | K152833 | Pruitt F3-S Polyurethane Carotid Shunt LeMaitre Vascular, Inc. | MJN |
| Aug 27, 2015 | K143454 | Pruitt F3-S Carotid Shunt LeMaitre Vascular, Inc. | MJN |
| Oct 17, 2014 | K142660 | Antegrade LeMills Valvulotome LeMaitre Vascular, Inc. | MGZ |
| Apr 10, 2014 | K140042 | 1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME LeMaitre Vascular, Inc. | MGZ |
| Dec 31, 2013 | K133026 | UNBALLOON NON-OCCLUSION MODELING CATHETER LeMaitre Vascular, Inc. | DQY |
| Nov 6, 2013 | K132022 | LEMAITRE 8F OCCLUSION CATHETER LeMaitre Vascular, Inc. | MJN |
| Nov 5, 2013 | K132047 | LEMILLS VALVULOTOME LeMaitre Vascular, Inc. | MGZ |
| Aug 5, 2013 | K132190 | EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOME LeMaitre Vascular, Inc. | MGZ |
| Feb 5, 2013 | K130016 | LIFESPAN EPTFE VASCULAR GRAFT LeMaitre Vascular, Inc. | DSY |
| Dec 14, 2012 | K123531 | UNBALLOON NON-OCCLUSIVE MODELING CATHETER LeMaitre Vascular, Inc. | DQY |
| Sep 5, 2012 | K121415 | MOLLRING MULTITASC LeMaitre Vascular, Inc. | DWX |
| Aug 8, 2012 | K121839 | UNBALLOON NON-OCCLUSIVE MODELING CATHETER LeMaitre Vascular, Inc. | DQY |
| Sep 13, 2011 | K110891 | THE UNBALLOON NON-OCCLUSIVE CATHETER; THE UNBALLOON NON-OCCLUSIVE MODELING CATHETER LeMaitre Vascular, Inc. | DQY |
| Jul 29, 2011 | K111884 | OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOME LeMaitre Vascular, Inc. | MGZ |
| Jan 19, 2011 | K103080 | ALBOGRAFT VASCULAR PROSTHESIS LeMaitre Vascular, Inc. | MAL |
| Dec 8, 2010 | K103356 | PRUITT CAROTID KIT LeMaitre Vascular, Inc. | MJN |
| Sep 20, 2010 | K101740 | ALBOSURE POLYESTER VASCULAR PATCH LeMaitre Vascular, Inc. | DXZ |
| Apr 23, 2010 | K091987 | ANASTOCLIP MODELS 4001-01, 4000-02, 4000-03, 4000-04, 4004-01, 4004-02, ANASTOCLIP LeMaitre Vascular, Inc. | FZP |
| Jan 14, 2010 | K093231 | ALBOGRAFT VASCULAR PROSTHESIS LeMaitre Vascular, Inc. | MAL |
| Jan 27, 2009 | K081878 | LEMAITRE TT TORTUOUS TRACKER INTRODUCER CATHETER DELIVERY SYSTEM LeMaitre Vascular, Inc. | DQY |
| Aug 29, 2007 | K071367 | FLEXCEL CAROTID SHUNT (INLYING), MODEL 2020-05 LeMaitre Vascular, Inc. | MJN |
| May 27, 2005 | K051067 | PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT) LeMaitre Vascular, Inc. | MJN |
| Dec 3, 2004 | K043023 | PRUITT-INAHARA OUTLYING CAROTID SHUNT, MODELS, 2012-49, 2013-49, 2014-49,2015-49,2016-49, 2017-49 LeMaitre Vascular, Inc. | MJN |
| Dec 19, 2003 | K033159 | LEMAITRE VASCULAR STRAIGHT CAROTID SHUNT, MODEL 2002-01, 2002-05, 2003-01, 2003-05, 2004-01, 2004-05, 2005-01, 2005-05 LeMaitre Vascular, Inc. | MJN |
| Aug 27, 2003 | K032041 | DISTAL PERFUSION CATHETER (1.5 CM) AND (2.5CM) LeMaitre Vascular, Inc. | DWF |
| Aug 5, 2003 | K031282 | OPTILOCK IMPLANTABLE ACCESS PORT, MODEL 1700-05 LeMaitre Vascular, Inc. | LJT |
| Feb 12, 2003 | K021580 | OPTILOCK IMPLANTABLE ACCESS PORT, MODELS #1700-01, 1700-02, 1700-03, 1700-04 AND 1700-05 LeMaitre Vascular, Inc. | LJT |
| Jan 30, 2003 | K023688 | LEMAITRE VASCULAR DISPOSABLE VEIN STRIPPER LeMaitre Vascular, Inc. | GAF |
| Jan 14, 2003 | K022145 | OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302 LeMaitre Vascular, Inc. | DXE |
Latest recalls
| 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 |
| Mar 19, 2026 | LeMaitre Vascular, Inc. Artegraft Vascular Graft;
REF#: AG740; Open, Classified |
LXA | None listed |
| Oct 23, 2025 | LeMaitre Vascular, Inc. Artegraft Collagen Vascular Graft;
REF: AG1015; Open, Classified |
LXA | None listed |
| Oct 8, 2025 | LeMaitre Vascular, Inc. Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG845M.
The Artegraft is intended to serve as a substitute conduit for blood where bypass or replace Open, Classified |
LXA | None listed |
| Oct 2, 2025 | LeMaitre Vascular, Inc. Artegraft Collagen Vascular Grafts
Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG 715, (7) AG 730, (8) AG 735, (9) AG 740, (10) AG 745, (11) AG 750, (12) AG 830, (13 Open, Classified |
LXA | None listed |
| May 12, 2025 | LeMaitre Vascular, Inc. Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09. Open, Classified |
DQT | K880231 |
| May 12, 2025 | LeMaitre Vascular, Inc. Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56 Open, Classified |
DYG | K811276 |
| 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 |
| Aug 28, 2023 | LeMaitre Vascular, Inc. The Chevalier Valvulotome is a device used to disrupt the valves of veins which are to be used as grafts in the in situ or non-reversed bypass procedure. The Chevalier Valvulotome consists of a 70 cm Open, Classified |
MGZ | None listed |
| 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 |
| Apr 6, 2021 | LeMaitre Vascular, Inc. LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Product Usage: intended to be used to perfuse contrast medias into the vessels for angiographic procedures, Catalog #: 4100-0 Terminated |
DXT | K973334 |
| 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 |
| Jul 24, 2019 | LeMaitre Vascular, Inc. The LeMaitre Aortic Occlusion Catheter is a single lumen catheter with a latex balloon, it is offered in two balloon sizes: 28 mm or 45mm. The single lumen acts as the inflation lumen for the balloon Terminated |
MJN | K132022 |
| Oct 1, 2018 | LeMaitre Vascular, Inc. LeMaitre Vascular Pruitt F3-S Polyurethane Outlying Carotid Shunt, Sterile
Model # 2014-10 Terminated |
MJN | K152833 |
| Jun 19, 2018 | LeMaitre Vascular, Inc. AnastoClip GC Closure System, REF# 4007-08 a closure system designed to penetrate the outer layers of tissue during the forming of an anastomosis or closing of a vessel with possible intraluminal pene Terminated |
HBT | K173323 |
| Feb 7, 2017 | LeMaitre Vascular, Inc. LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter with Introducer (paper IFU)
REF# 2401-53 Terminated |
DQO | None listed |
| Feb 7, 2017 | LeMaitre Vascular, Inc. LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU)
REF# e2401-53 Terminated |
DQO | None listed |
| Feb 7, 2017 | LeMaitre Vascular, Inc. LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (paper IFU)
REF# 2401-52 Terminated |
DQO | None listed |
| Feb 7, 2017 | LeMaitre Vascular, Inc. LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU)
REF# e2401-52 Terminated |
DQO | None listed |
| Feb 7, 2017 | LeMaitre Vascular, Inc. LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (paper IFU)
REF# 2401-51 Terminated |
DQO | None listed |
| Feb 7, 2017 | LeMaitre Vascular, Inc. LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter with Introducer (eIFU)
REF# e2401-51 Terminated |
DQO | None listed |
| Feb 7, 2017 | LeMaitre Vascular, Inc. LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter (paper IFU)
REF# 2401-50 Terminated |
DQO | None listed |
| Feb 7, 2017 | LeMaitre Vascular, Inc. LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter (eIFU)
REF# e2401-50 Terminated |
DQO | None listed |
| Feb 7, 2017 | LeMaitre Vascular, Inc. LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (eIFU)
REF # e2400-53 Terminated |
DQO | None listed |
| Feb 7, 2017 | LeMaitre Vascular, Inc. LeMaitre Vascular Reddick Cholangiogram Catheter with introducer(eIFU)
REF # e2400-52 Terminated |
DQO | None listed |
| Feb 7, 2017 | LeMaitre Vascular, Inc. LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter (eIFU)
REF# e2400-51 Terminated |
DQO | None listed |
| Feb 7, 2017 | LeMaitre Vascular, Inc. LeMaitre Vascular Reddick Cholangiogram Catheter (eIFU)
REF# e2400-50 Terminated |
DQO | None listed |
| Aug 3, 2016 | LeMaitre Vascular, Inc. 1.5 mm HYDRO LeMaitre Valvulotome, 40 cm. Sterile
REF # 1010-00
Product Usage:
The HYDRO LeMaitre Valvulotome is intended for the treatment of vascular disorders and more particularly for excising or Terminated |
MGZ | K140042 |
| Aug 3, 2016 | LeMaitre Vascular, Inc. 1.5 mm HYDRO LeMaitre Valvulotome without LeMills, 98 cm. Sterile
REF# 1009-00J
Product Usage:
The HYDRO LeMaitre Valvulotome is intended for the treatment of vascular disorders and more particularly Terminated |
MGZ | K140042 |
| Aug 3, 2016 | LeMaitre Vascular, Inc. 1.5 mm HYDRO LeMaitre Valvulotome, 98 cm, Sterile
REF # 1009-00
Product Usage:
The HYDRO LeMaitre Valvulotome is intended for the treatment of vascular disorders and more particularly for excising o Terminated |
MGZ | K140042 |
| Jun 22, 2016 | LeMaitre Vascular, Inc. AnastoCiip Universal Clip Remover (1Each}
REF# e4001-04
The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Re Terminated |
FZP | K962043 |
| Jun 22, 2016 | LeMaitre Vascular, Inc. AnastoCiip Universal Clip Remover (6 Pack}
REF# e4001-00
The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Terminated |
FZP | K962043 |
| Jun 22, 2016 | LeMaitre Vascular, Inc. AnastoCiip Universal Clip Remover (1Each}
REF# 4001-04
The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Re Terminated |
FZP | K962043 |
| Jun 22, 2016 | LeMaitre Vascular, Inc. AnastoCiip Universal Clip Remover (6 Pack}
REF# 4001-00
The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Terminated |
FZP | K962043 |
| Jun 22, 2016 | LeMaitre Vascular, Inc. Anasto AC Closure System and Anasto Universal Clip Remover- Anasto AC 8cm 25 Clips (1 Each} X-Large
REF # 4000-08
The Anastoclip Clip applier consists of a rotating shaft and an integral cartridg Terminated |
FZP | K962043 |
| Jun 22, 2016 | LeMaitre Vascular, Inc. AnastoClip AC 8cm 35 Clips (1 Each} Large
REF # 4000-07
The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip R Terminated |
FZP | K962043 |
| Jun 22, 2016 | LeMaitre Vascular, Inc. Anastoclip AC 8cm 35 Clips (1 Each} Medium
REF # 4000-06
The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip R Terminated |
FZP | K962043 |
| 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 |
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