LeMaitre Vascular, Inc.

Entity profile compiled from public source records

Public Record Profile Registrations: 2 510(k) filings: 1 Recalls: 2

Known Identifiers & Locations

FEI Numbers 1000121696, 1220948
Owner Operator Numbers 1220948, 9006148
Locations Covered BURLINGTON, MA, US; N Brunswick, NJ, US

Registered Establishments (2)

Registration # Establishment Name Location Establishment Type(s) Action
1220948 LEMAITRE VASCULAR, INC. BURLINGTON, MA, US Manufacture Medical Device View Details
2247686 LEMAITRE VASCULAR, INC. N Brunswick, NJ, US Manufacture Medical Device View Details

510(k) Premarket Notifications (1)

Submission # Device Name Decision Date Decision Description Action
K051067 PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT) 2005-05-27 Substantially Equivalent View Details

FDA Recall History (2)

Recall # Product Description Initiation Date Status Action
Z-0008-2008 CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035 (Cardiovascular Innovations LLC) Reason: Sterility of device may be compromised due to breach in sterile barrier. 2007-07-18 Terminated View Details
Z-0034-2026 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; Reason: The bovine carotid arteries used to produce the impacted grafts from affected lots were sourced using raw material from a supplier that had not been reviewed and approved by the appropriate regulatory authority. 2025-09-02 Open, Classified View Details

Profile Disclaimer

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