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

    INDIGO Aspiration System

    K Number: K163618 · Decision May 24, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    2
    Applicant Total
    87
    Review Days
    153

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    INDIGO Aspiration System
    K Number
    K163618
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5150
    Medical Specialty
    Cardiovascular
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Penumbra, Inc.
    Date Received
    December 22, 2016
    Decision Date
    May 24, 2017
    Product Code
    QEX
    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
    QEX Coronary Mechanical Thrombectomy With Aspiration

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (QEX), ordered by most recent decision date.

    NeVa PV Thrombectomy Device

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MegaVac Mechanical Thrombectomy System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Penumbra, Inc.

    K Number Device Name
    K250690 Penumbra System (Thunderbolt Aspiration Tubing)
    K260599 INDIGO® Aspiration System – INDIGO Link
    K251949 INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK
    K252612 INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration Tubing
    K250079 Ruby XL System
    K242104 Penumbra System (Reperfusion Catheter RED 72)
    K242033 Access25™ Delivery Microcatheter
    K242520 Element Vascular Access System
    K242075 Indigo® Aspiration System – Lightning Bolt Aspiration Tubing
    K242319 Indigo® Aspiration System – Aspiration Catheter 6X
    Search all 87 clearances from Penumbra, Inc. →