# LeMaitre Vascular, Inc.

- Location (FDA's records): Burlington, MA
- FDA decisions: 37 (1979–2022): 35 510(k) clearances and 2 original PMA approvals
- Names in FDA's records: LeMaitre Vascular, Inc. (34); Lemaitre Vascular (3)
- Product codes: MJN (9), MGZ (6), DQY (5), LJT (2), MAL (2), FZP (2), LXA (2), DWX (1), PSQ (1), DXZ (1), DWQ (1), DWF (1)
- 510(k) review time since 2016: median 114 days, against 110 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 36 (15 its own); citations of its devices by later devices: 18 (15 its own)
- Recalls linked to its devices: 37 (18 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Pm Devices, Inc.: 2 (https://510kreport.com/company/pm-devices)
- Meadox Medicals, Div. Boston Scientific Corp.: 2 (https://510kreport.com/company/meadox-medicals-div-boston-scientific)
- Edwards Lifesciences, LLC: 2 (https://510kreport.com/company/edwards-lifesciences)
- Baxter Healthcare Corp: 2 (https://510kreport.com/company/baxter-healthcare)
- Cardio Vascular Concepts, Inc.: 1 (https://510kreport.com/company/cardio-vascular-concepts)
- Cook, Inc.: 1 (https://510kreport.com/company/cook)
- Medtronic Endovascular Innovations: 1 (https://510kreport.com/company/medtronic-endovascular-innovations)
- W. L. Gore & Associates, Inc.: 1 (https://510kreport.com/company/w-l-gore-associates)

## Firms that cite its devices most
- LimFlow, Inc.: 1 (https://510kreport.com/company/limflow)
- Aveera Medical, Inc.: 1 (https://510kreport.com/company/aveera-medical)
- Genesis Medical Interventional, Inc.: 1 (https://510kreport.com/company/genesis-medical-interventional)

## Its most-cited devices
- K051067: Pruitt F3 Outlying and Inlying Carotid Shunt (with and Without T-Port) (2005), cited by 4
- K110891: The Unballoon Non-Occlusive Catheter; the Unballoon Non-Occlusive Modeling Catheter (2011), cited by 3
- K132190: Expandable Lemaitre Valvulotome, Over-the-Wire Lemaitre Valvulotome (2013), cited by 3
- K121839: Unballoon Non-Occlusive Modeling Catheter (2012), cited by 2
- K033159: Lemaitre Vascular Straight Carotid Shunt, Model 2002-01, 2002-05, 2003-01, 2003-05, 2004-01, 2004-05, 2005-01, 2005-05 (2003), cited by 1
- K123531: Unballoon Non-Occlusive Modeling Catheter (2012), cited by 1

## Recent decisions
- K212894: PhasTIPP (Mar 31, 2022)
- K190882: XenoSure Biologic Patch (Feb 13, 2020)
- K190267: EZE SIT Valvulotome (Oct 30, 2019)
- K183513: XenoSure Dura Biologic Patch (Jun 13, 2019)
- K182916: Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr (Nov 16, 2018)
- K173323: AnastoClip GC Closure System (Mar 8, 2018)
- K152833: Pruitt F3-S Polyurethane Carotid Shunt (Jan 21, 2016)
- K143454: Pruitt F3-S Carotid Shunt (Aug 27, 2015)

Source page: https://510kreport.com/company/lemaitre-vascular