BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Inno-Pathwire

    K Number: K182553 · Decision Mar 11, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    257
    Registration Numbers
    258
    Same Product Code
    763
    Applicant Total
    2
    Review Days
    175

    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
    Inno-Pathwire
    K Number
    K182553
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Suzhou Innomed Medical Device Co., Ltd.
    Date Received
    September 17, 2018
    Decision Date
    March 11, 2019
    Product Code
    DQX
    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
    DQX Wire, Guide, Catheter

    Similar 510(k) Clearances

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

    InQwire Amplatz Guide Wire

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Enroute 0.014'' Transcarotid Guidewire

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EmeryGlide™ (EG18008901)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S)

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

    Other Clearances by Suzhou Innomed Medical Device Co., Ltd.

    K Number Device Name
    K172187 Inno-Hydrowire