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

    PathBuilder Transseptal Needle

    K Number: K212625 · Decision Mar 23, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    50
    Applicant Total
    4
    Review Days
    217

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    Basic Information

    Device Name
    PathBuilder Transseptal Needle
    K Number
    K212625
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1390
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shanghai Microport EP Medtech Co., Ltd.
    Date Received
    August 18, 2021
    Decision Date
    March 23, 2022
    Product Code
    DRC
    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
    DRC Trocar

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    Other Clearances by Shanghai Microport EP Medtech Co., Ltd.

    K Number Device Name
    K210313 EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter
    K212626 PathBuilder Transseptal Guiding Introducer
    K211530 PathBuilder Steerable Introducer