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

    Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate Tubing

    K Number: K243418 · Decision Dec 2, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    76
    Applicant Total
    32
    Review Days
    28

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    Basic Information

    Device Name
    Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate Tubing
    K Number
    K243418
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4780
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
    Date Received
    November 4, 2024
    Decision Date
    December 2, 2024
    Product Code
    JCX
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered

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    Other Clearances by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

    K Number Device Name
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    K243080 Riptide Aspiration System
    K211990 Rist 071 Radial Access Guide Catheter
    K203432 Axium Detachable Coil; Axium Prime Detachable Coil
    K203358 Solitaire X Revascularization Device
    K202850 Concerto Versa, Detachable Coil
    K193576 Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device)
    K202318 Marathon Flow Directed Micro Catheter
    K201690 Mirage Hydrophilic Guidewire; X-pedion Hydrophilic Guidewire
    K201689 Riptide Aspiration System
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