BEUDAMED
    FDA Registration Active 🇺🇸 United States

    VESALIO

    Reg #: 3014498720 · FEI: 3014498720 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    27
    Establishment Types
    4
    Classifications
    8

    Registration Details

    Registration Name
    VESALIO
    Registration Number
    3014498720
    FEI Number
    3014498720
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2305 Historic Decatur Rd, Suite 100
    City
    San Diego
    State
    CA
    ZIP
    92106
    Country
    US

    Regulatory Submissions

    510(k) Number
    K251312
    PMA Number
    H210004

    Owner / Operator

    Firm Name
    Vesalio, Inc
    Operator Number
    10057432
    Address
    5800 Granite Parkway, Suite 470
    City
    Plano
    State
    TX
    Postal Code
    75024
    Country
    US

    Products

    Device Name Product Code
    Aspiration Thrombectomy Catheter QEZ
    Peripheral Mechanical Thrombectomy With Aspiration QEW
    Catheter, Continuous Flush KRA
    Catheter, Thrombus Retriever NRY
    Coronary Mechanical Thrombectomy With Aspiration QEX
    Temporary Percutaneous Transluminal Cerebral Artery Dilatation Device QTK
    Catheter, Percutaneous DQY
    Catheter, Percutaneous, Neurovasculature QJP

    Proprietary Names

    pVasc Aspiration Catheter System NeVa pVasc Thrombectomy Device VP-6035-F2RR NeVa pVasc Thrombectomy Device VP-4537-F2RR NeVa pVasc Thrombectomy Device VP-4038-F3RX NeVa pVasc Thrombectomy Device VP-4030-F2RR NeVa pVasc Thrombectomy Device VP-4022-02RX NeVa pVasc Thrombectomy Device VP-4546-F3RX NeVa pVasc Thrombectomy Device VP-6044-F3RR NeVa pVasc Thrombectomy Device VP-4038-F3RR NeVa pVasc Thrombectomy Device VP-4537-F2RX NeVa pVasc Thrombectomy Device VP-4544-05RR NeVa pVasc Thrombectomy Device VP-4546-F3RR NeVa pVasc Thrombectomy Device VP-4030-F2RX NeVa pVasc Thrombectomy Device VP-4022-02RR NeVa pVasc Thrombectomy Device VP-4529-03RX NeVa pVasc Thrombectomy Device VP-4529-03RR NeVa VSx NeVa M1-Sx NeVa VS NeVa M1-S NeVa M1 NeVa M1x NeVa Tx NeVa T enVast Coronary Thrombectomy System NeVasc Aspiration System pVasc Aspiration System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Manufacture Device in the United States for Export Only