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

    ZYNERGY Z3K BALLOON GUIDED PACING AND MONITORING CATHETER

    K Number: K010099 · Decision Feb 1, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    128
    Applicant Total
    6
    Review Days
    21

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    Basic Information

    Device Name
    ZYNERGY Z3K BALLOON GUIDED PACING AND MONITORING CATHETER
    K Number
    K010099
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.3680
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zcv ,Inc.
    Date Received
    January 11, 2001
    Decision Date
    February 1, 2001
    Product Code
    LDF
    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
    LDF Electrode, Pacemaker, Temporary

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    Other Clearances by Zcv ,Inc.

    K Number Device Name
    K002603 ZYNERGY BALLOONPACE BALLOON GUIDED PACING AND MONITORING CATHETER
    K003118 Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0
    K002481 ZYNERGY FEATHERPACE TRANSVENOUS BIPOLAR CATHETER, MODEL 04-X-02-3-10-3
    K991060 ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, MODEL Z50000
    K990689 ZYNERGY LOCK-SURE SINGLE PASS DRAINAGE CATHETER, Z10005/7/9