BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ENABLECV, LLC

    Reg #: 3031571797 · FEI: 3031571797 · Expires 2026
    View on FDA
    Products
    11
    Proprietary Names
    52
    Establishment Types
    1
    Classifications
    11

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    Registration Details

    Registration Name
    ENABLECV, LLC
    Registration Number
    3031571797
    FEI Number
    3031571797
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    6967 S River Gate Dr. Ste 104
    City
    Midvale
    State
    UT
    ZIP
    84047
    Country
    US

    Regulatory Submissions

    510(k) Number
    K981009

    Owner / Operator

    Firm Name
    enableCV, LLC
    Operator Number
    10092279
    Address
    6967 S River Gate Dr. Ste 104
    City
    Midvale
    State
    UT
    Postal Code
    84047
    Country
    US
    Correspondent
    Hannah R Putnam

    Products

    Device Name Product Code
    Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass DWF
    Clamp, Vascular DXC
    Filter, Blood, Cardiopulmonary Bypass, Arterial Line DTM
    Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL
    Catheter, Intravascular, Diagnostic DQO
    Lavage, Jet FQH
    Introducer, Catheter DYB
    Cannula, Catheter DQR
    Stabilizer, Heart MWS
    Suction Control, Intracardiac, Cardiopulmonary Bypass DWD
    Dilator, Vessel, For Percutaneous Catheterization DRE

    Proprietary Names

    Thruport Endovent Pulmonary Catheters Carotid shunts Thruport Endoclamp Aortic Catheters Thruport Endodirect Arterial Cannula Axillary Access Arterial Cannulae Femoral Access Arterial; Venous Cannulae (FEMS) Embol-X Arterial Filter EMBOL-X ARTERIAL FILTER Cardioplegia Delivery Sets Left Atrial Pressure Monitoring Catheter ProPlege Peripheral Retrograde Cardioplegia Device EndoReturn Arterial Cannulae Vent Catheters Vascushunt carotid shunts VisuFlo Blower Port Access EV cardiopulmonary bypass system INTRODUCER SHEATH KIT, 9 FR Arterial Cannula Families (EZ Glide, OptiSite and EndoReturn) OptiSite Arterial Cannula Percutaneous Insertion Kit (PIKA5 - Arterial, PIKV5 - Venous) Retrograde Cardioplegia Catheters QuickDraw™ Plus Venous Cannula (QDP25) Aortic Perfusion Cannulae; Pediatric Peripheral access arterial cannula FAPCath Femoral arterial pressure monitoring catheter Porous Vent plugs FEM-FELX, FEX-FLEX II FEMORAL ACCESS CANNULA FemTrak Femoral Venous Cannula Fem-Flex II Femoral Arterial Cannula; Fem-Flex II Femoral Venous Cannula; Femoral Venous Cannula EMBOL-X Introducer Sheath; EXIS Anastaflo Intravascular Shunts Thruport Endoplege Coronary Sinus Catheter Cardioplegia Kits Intraclude Intra-Aortic Occlusion Device Janke-Barron Heart Support Embol-X arterial cannulae Duraflo-Treated Suction Wands Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Aortic Perfusion Cannulae - EZ Glide Single Stage Venous Drainage Cannula INTRODUCER SHEATH KIT,11 FR Arterial Perfusion Cannulae Introducer, Catheter - Introducer Sheath (IS19A) Tapered carotid bypass shunts Dilator Kit Vasoplegia cannulae Duraflo-treated femoral cannulae Antegrade Cardioplegia Cannula IntraClude - INTRA-AORTIC OCCLUSION DEVICE Cardioplegia delivery monitoring and infusion sets IntraClude Intra-Aortic Occlusion Catheter Internal Mammary Artery Cannulae Pressure monitoring extension lines Suction Wands and Sumps

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility