BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    Epicardial Access System

    K Number: K213582 · Decision Jun 30, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    273
    Registration Numbers
    273
    Same Product Code
    701
    Applicant Total
    24
    Review Days
    230

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    Basic Information

    Device Name
    Epicardial Access System
    K Number
    K213582
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Baylis Medical Company, Inc.
    Date Received
    November 12, 2021
    Decision Date
    June 30, 2022
    Product Code
    DYB
    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
    DYB Introducer, Catheter

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