510(k) Report

FDA applicant

LeMaitre Vascular, Inc.

Burlington, MA37 decisions1979–202237 recalls

FDA records 37 decisions for LeMaitre Vascular, Inc. (Burlington, MA) from 1979 to 2022: 35 510(k) clearances and 2 original PMA approvals. Most are in product codes MJN (Catheter, Intravascular Occluding, Temporary) and MGZ (Valvulotome). Since 2016 its 510(k)s took a median of 114 days from receipt to decision, against 110 for FDA’s reviews in the same codes and years. Its devices cite 36 predicates, 15 of them its own earlier devices. 37 recalls are linked to its devices, 18 Class I.

FDA’s records also spell it “Lemaitre Vascular”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided LeMaitre Vascular, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2007: 12009: 12010: 42011: 32012: 32013: 52014: 22015: 12016: 12018: 22019: 22020: 12022: 1
2007high 5 (2013) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2026

2010: 22011: 12013: 17, 17 Class I2015: 82016: 32018: 22019: 12020: 1, 1 Class I2025: 12026 (partial year): 1
2007high 17 (2013) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — LeMaitre Vascular, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like LeMaitre Vascular, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • MJNCatheter, Intravascular Occluding, Temporary9decisions
  • MGZValvulotome6decisions
  • DQYCatheter, Percutaneous5decisions
  • LJTPort & Catheter, Implanted, Subcutaneous, Intravascular2decisions
  • MALGraft, Vascular, Synthetic/Biologic Composite2decisions
  • FZPClip, Implantable2decisions

Also: LXA (2), DWX (1), PSQ (1), DXZ (1), DWQ (1), DWF (1).

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 114 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 110 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 36 predicates; 15 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 18 times; 15 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K051067Pruitt F3 Outlying and Inlying Carotid Shunt (with and Without T-Port)LeMaitre Vascular, Inc. · 20054cite it
  • K110891The Unballoon Non-Occlusive Catheter; the Unballoon Non-Occlusive Modeling CatheterLeMaitre Vascular, Inc. · 20113cite it
  • K132190Expandable Lemaitre Valvulotome, Over-the-Wire Lemaitre ValvulotomeLeMaitre Vascular, Inc. · 20133cite it
  • K121839Unballoon Non-Occlusive Modeling CatheterLeMaitre Vascular, Inc. · 20122cite it
  • K033159Lemaitre Vascular Straight Carotid Shunt, Model 2002-01, 2002-05, 2003-01, 2003-05, 2004-01, 2004-05…LeMaitre Vascular, Inc. · 20031cites it
  • K123531Unballoon Non-Occlusive Modeling CatheterLeMaitre Vascular, Inc. · 20121cites it

What has FDA decided for it lately?

  • K212894PhasTIPPLeMaitre Vascular, Inc. · 2022
  • K190882XenoSure Biologic PatchLemaitre Vascular · 2020
  • K190267EZE SIT ValvulotomeLemaitre Vascular · 2019
  • K183513XenoSure Dura Biologic PatchLeMaitre Vascular, Inc. · 2019
  • K182916Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 FrLemaitre Vascular · 2018
  • K173323AnastoClip GC Closure SystemLeMaitre Vascular, Inc. · 20181 recall
  • K152833Pruitt F3-S Polyurethane Carotid ShuntLeMaitre Vascular, Inc. · 20161 recall
  • K143454Pruitt F3-S Carotid ShuntLeMaitre Vascular, Inc. · 2015

All 34 as LeMaitre Vascular, Inc. →All 3 as Lemaitre Vascular →

What has been recalled?

37 recalls linked to its devices; the latest:

  • K022145TufTex Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88;Aug 28, 2026Class II
  • K022145TufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651-38…Apr 11, 2025Class II
  • K022145LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84…Mar 23, 2020Class I
  • K132022The LeMaitre Aortic Occlusion Catheter is a single lumen catheter with a latex balloon…Jul 24, 2019Class II
  • K152833LeMaitre Vascular Pruitt F3-S Polyurethane Outlying Carotid Shunt, Sterile Model # 2014-10Oct 1, 2018Class II
  • K173323AnastoClip GC Closure System, REF# 4007-08 a closure system designed to penetrate the…Jun 19, 2018Class II