BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent - Subject to Tracking Reg. 🇺🇸 United States

    A1-CS-SB Y-ADAPTER, MODEL 124 871

    K Number: K003454 · Decision Jan 18, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    102
    Applicant Total
    85
    Review Days
    72

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    Basic Information

    Device Name
    A1-CS-SB Y-ADAPTER, MODEL 124 871
    K Number
    K003454
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.3620
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent - Subject to Tracking Reg.
    Applicant
    Biotronik, Inc.
    Date Received
    November 7, 2000
    Decision Date
    January 18, 2001
    Product Code
    DTD
    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
    DTD Pacemaker Lead Adaptor

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