BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    VASCULAR SOLUTIONS PRONTO SHORT EXTRACTION CATHETER

    K Number: K051193 · Decision Aug 8, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    91
    Applicant Total
    103
    Review Days
    90

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    Basic Information

    Device Name
    VASCULAR SOLUTIONS PRONTO SHORT EXTRACTION CATHETER
    K Number
    K051193
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5150
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vascular Solutions, Inc.
    Date Received
    May 10, 2005
    Decision Date
    August 8, 2005
    Product Code
    QEZ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QEZ Aspiration Thrombectomy Catheter

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    Other Clearances by Vascular Solutions, Inc.

    K Number Device Name
    K182232 Octane Mechanical Thrombectomy System
    K181647 Bandit guidewire
    K180913 VSI Micro-Introducer Kit
    K180088 TrapLiner catheter
    K180128 Warrior 14 guidewire
    K173891 Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume
    K173532 Raider Guidewire
    K173266 Octane aspiration system
    K170544 Langston dual lumen catheter
    K171946 Gel-Bead
    Search all 103 clearances from Vascular Solutions, Inc. →