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    R3 VASCULAR, INC.

    FDA registration
    R3 VASCULAR, INC.·1 product·🇺🇸 United States

    LeMaitre Vascular, Inc 63 Second Avenue Burlington, Massachusetts 01803

    Manufacturer
    🇺🇸 United States·7 Basic UDI-DIs·10 Devices·1 Importer·TÜV SÜD Product Service GmbH and TÜV SÜD Product Service GmbH

    R4 VASCULAR INC. PEGASUS CT PICC, MODEL 500005-001,002, 004, 005, 500004-001, 002,004,005

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VALVULOTOMES, SINGLE-USE

    Device
    EU MDR · Eu Md Class 2a ·LeMaitre Vascular, Inc 63 Second Avenue Burlington, Massachusetts 01803·On the market·1 country

    VALVULOTOMES, SINGLE-USE

    Device
    EU MDR · Eu Md Class 2a ·LeMaitre Vascular, Inc 63 Second Avenue Burlington, Massachusetts 01803·On the market·1 country

    VALVULOTOMES, SINGLE-USE

    Device
    EU MDR · Eu Md Class 2a ·LeMaitre Vascular, Inc 63 Second Avenue Burlington, Massachusetts 01803·On the market·1 country

    Eze-Sit® Valvulotome

    Device
    EU MDR · Eu Md Class 2a ·LeMaitre Vascular, Inc 63 Second Avenue Burlington, Massachusetts 01803·On the market·1 country

    LeMaitre® Valvulotome

    Device
    EU MDR · Eu Md Class 2a ·LeMaitre Vascular, Inc 63 Second Avenue Burlington, Massachusetts 01803·On the market·1 country

    XenoSure® Biologic Patch

    Device
    EU MDD · Eu Md Class 3 ·LeMaitre Vascular, Inc 63 Second Avenue Burlington, Massachusetts 01803·On the market·31 countries

    XenoSure® Biologic Patch

    Device
    EU MDD · Eu Md Class 3 ·LeMaitre Vascular, Inc 63 Second Avenue Burlington, Massachusetts 01803·On the market·31 countries

    PERICARDIUM VASCULAR PATCHES

    Device
    EU MDD · Eu Md Class 3 ·LeMaitre Vascular, Inc 63 Second Avenue Burlington, Massachusetts 01803·On the market·31 countries

    XenoSure®

    Device
    EU MDD · Eu Md Class 3 ·LeMaitre Vascular, Inc 63 Second Avenue Burlington, Massachusetts 01803·On the market·31 countries

    LeMaitre Valvulotome

    Device
    EU MDR · Eu Md Class 2a ·LeMaitre Vascular, Inc 63 Second Avenue Burlington, Massachusetts 01803·On the market·32 countries

    DURASPAN HEMODIALYSIS CATHETER

    FDA Adverse Event
    Malfunction ·R4 VASCULAR INC.·Product code MSD·September 28, 2010

    DuraspanTM Dialysis Catheters, Ultra and Long Term, 15.5 Fr, Sterile EO, Manufactured for r4 Vascular, Inc . 7550 Meridan Circle North, Suite 150, Maple Grove, MN 55369. Description Model # Duraspan Kit - 24cm 62152420 Duraspan Kit - 28cm 62152820 Duraspan Kit - 32cm 62153220 Duraspan Exchange Kit - 32cm 62153228 Duraspan Kit - 36cm 62153620 Duraspan Exchange Kit - 36cm 62153628 Duraspan Kit - 40cm 62154020 Duraspan Exchange Kit - 40cm 62154028 Duraspan Kit - 55cm 62155520 Duraspan Ultra Kit - 24cm 621524E0 Duraspan Ultra Kit - 28cm 621528E0 Duraspan Ultra Kit - 36cm 621536E0 Duraspan Ultra Kit - 40cm 621540E0 Duraspan Ultra Kit - 55cm 621555E0 The r4 DuraspanTM and the DuraspanTM Ultra long-term dialysis catheter are indicated for attaining short and long term (>30 days) vascular access for hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the internal jugular vein, external jugular vein, subclavian vein or femoral vein. Catheters 40 cm and longer are for femoral vein insertion. The ability of the Biomimetic Coating to reduce platelet adhesion and thrombus accumulation is supported exclusively by in-vitro and animal testing.

    FDA Recall
    Terminated ·R4 Vascular Inc·Product code MSD·May 3, 2011

    DURA-GUARD

    FDA Adverse Event
    Injury ·BIO-VASCULAR, INC.·Product code GXQ·September 22, 1997

    DURA-GUARD

    FDA Adverse Event
    Injury ·BIO-VASCULAR, INC.·Product code GXQ·September 22, 1997

    LeMaitre Vascular GmbH

    Authorized representative
    🇩🇪 Germany·2 Manufacturers·10 Devices

    Chevalier Valvulotome

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·LeMaitre Vascular, Inc 63 Second Avenue Burlington, Massachusetts 01803·3 devices

    Eze-Sit Valvulotome

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·LeMaitre Vascular, Inc 63 Second Avenue Burlington, Massachusetts 01803·1 device