LeMaitre Vascular, Inc.: FDA filings under this applicant name
FDA lists 35 510(k) clearances under 2 spellings of the applicant name “LeMaitre Vascular, Inc.” (first 2003, latest 2022), plus 2 PMA decisions, across 16 product codes in 4 review panels. Median 510(k) review time under this name: 96 days. Since 2017 the median was 190 days, against 109 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 47 |
| 2013 | 5 | 96 |
| 2014 | 2 | 60 |
| 2015 | 1 | 267 |
| 2016 | 1 | 114 |
| 2017 | 0 | — |
| 2018 | 2 | 84 |
| 2019 | 2 | 220 |
| 2020 | 1 | 315 |
| 2021 | 0 | — |
| 2022 | 1 | 202 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name LeMaitre Vascular, Inc. took a median 190 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 109 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MJN | Catheter, Intravascular Occluding, Temporary | 9 | 9 |
| MGZ | Valvulotome | 6 | 6 |
| DQY | Catheter, Percutaneous | 5 | 5 |
| FZP | Clip, Implantable | 2 | 2 |
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 2 | 2 |
| LXA | Tissue Graft Of 6mm And Greater | 2 | 0 |
| MAL | Graft, Vascular, Synthetic/Biologic Composite | 2 | 2 |
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | 1 | 1 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 1 | 1 |
| DWQ | Stripper, Vein, External | 1 | 1 |
Plus 6 more product codes.
Review panels
- Cardiovascular (31)
- General and Plastic Surgery (3)
- General Hospital (2)
- Neurology (1)
Most recent LeMaitre Vascular, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K212894 | PhasTIPP | DWQ | 2022-03-31 | 202 |
| K190882 | XenoSure Biologic Patch | PSQ | 2020-02-13 | 315 |
| K190267 | EZE SIT Valvulotome | MGZ | 2019-10-30 | 264 |
| K183513 | XenoSure Dura Biologic Patch | GXQ | 2019-06-13 | 177 |
| K182916 | Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr | MJN | 2018-11-16 | 29 |
| K173323 | AnastoClip GC Closure System | FZP | 2018-03-08 | 139 |
| K152833 | Pruitt F3-S Polyurethane Carotid Shunt | MJN | 2016-01-21 | 114 |
| K143454 | Pruitt F3-S Carotid Shunt | MJN | 2015-08-27 | 267 |
| K142660 | Antegrade LeMills Valvulotome | MGZ | 2014-10-17 | 29 |
| K140042 | 1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME | MGZ | 2014-04-10 | 92 |
25 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P020049 | PMA | PROCOL VASCULAR BIOPROSTHESIS | 2003-07-29 |
| N16837 | PMA | ARTEGRAFT{TM} AND REINFORCED ARTEGRAFT{TM} | 1979-08-01 |
Recalls
84 product recalls in 26 recall events; 10 initiated in the last five years. Most recent: 2026-02-10.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named LeMaitre Vascular, Inc. is the lead sponsor of 7 device studies on ClinicalTrials.gov (5 active or recruiting). Most recent:
- NCT04906824: Post-Market Registry in Europe and US for the Use of VascuCelTM (Active not recruiting, started 2023-06-09)
- NCT05386342: A PMCF Study Confirm the Performance and Safety of the TufTex Over-the-Wire (OTW) Embolectomy Catheters (Recruiting, started 2023-01-11)
- NCT05386277: A PMCF Study to Confirm the Performance and Safety of the LeMaitre® TufTex Single Lumen Embolectomy Catheter (Recruiting, started 2022-01-11)
- NCT04620889: LeMaitre LifeSpan® ePTFE Vascular Graft Retrospective Registry (Completed, started 2020-11-27)
- NCT04175327: Prospective and Non-randomized Registry of CardioCel 3D (Active not recruiting, started 2020-08-28)
SEC filings
LEMAITRE VASCULAR INC (LMAT): EDGAR filings, CIK 1158895. An SEC registrant with the same name, matched by name only.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- LeMaitre Vascular, Inc. (34)
- Lemaitre Vascular (3)
Frequently asked questions
How many FDA 510(k) clearances are listed under LeMaitre Vascular, Inc.?
FDA lists 35 510(k) clearances under 2 spellings of the applicant name “LeMaitre Vascular, Inc.” (first 2003, latest 2022), plus 2 PMA decisions, across 16 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by LeMaitre Vascular, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name LeMaitre Vascular, Inc. is 96 days. Since 2017: 190 days, versus 109 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under LeMaitre Vascular, Inc.?
The most frequent FDA product codes under this applicant name are MJN (Catheter, Intravascular Occluding, Temporary, 9); MGZ (Valvulotome, 6); DQY (Catheter, Percutaneous, 5).
Next steps
- See all 35 LeMaitre Vascular, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MJN, LeMaitre Vascular, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.