Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2247686

FEI Number

1000121696

Entity Name

LEMAITRE VASCULAR, INC.

City/State/Country

N Brunswick, NJ, US

Establishment Address

206 NORTH CENTER DR., N Brunswick, NJ 08902, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

LeMaitre Vascular, Inc. (Owner Number: 9006148)

Owner / Operator Contact Address

206 NORTH CENTER DR., --, North Brunswick, NJ 08902, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N16837

All Registered Proprietary Names

Artegraft Bovine Carotid Artery (BCA) Artegraft Collagen Vascular Graft Artegraft Vascular Graft

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXA	Tissue Graft Of 6mm And Greater	Unknown	Class 3	N/A	2007-12-31

Official Correspondent

Xiang Zhang

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

LeMaitre Vascular, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K051067	LeMaitre Vascular, Inc.	PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT)	2005-05-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0034-2026	LeMaitre Vascular, Inc.	3	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) AG 840, (14) AG 1015, (15) AG 1030;

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2247686. Last updated year: 2026. Please use registration number 2247686 when referencing this establishment in official correspondence.