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

    JETSTREAM G3 SE SYSTEM, JETSTREAM G3 SF SYSTEM MODEL PV31230 (JETSTREAM G3 SE CATHETER AND CONTROL POD); PVCN100 (PV CON

    K Number: K101334 · Decision Jun 11, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    144
    Applicant Total
    16
    Review Days
    30

    Basic Information

    Device Name
    JETSTREAM G3 SE SYSTEM, JETSTREAM G3 SF SYSTEM MODEL PV31230 (JETSTREAM G3 SE CATHETER AND CONTROL POD); PVCN100 (PV CON
    K Number
    K101334
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.4875
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    PATHWAY MEDICAL TECHNOLOGIES, INC.
    Date Received
    May 12, 2010
    Decision Date
    June 11, 2010
    Product Code
    MCW
    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
    MCW Catheter, Peripheral, Atherectomy

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    Other Clearances by PATHWAY MEDICAL TECHNOLOGIES, INC.

    K Number Device Name
    K120242 JETSTREAM NAVITUS L SYSTEM
    K111229 JETSTREAM G3 (R) SF 1.6 SYSTEM
    K110626 JETSTREAM NAVITUS SYSTEM; JETSTREAM G3 SF SYSTEM; JETSTREAM G3 SE SYSTEM; JETSTREAM G3 L SYSTEM
    K101221 JETSTREAM G3 SYSTEM, MODEL PV31300, PV CONSOLE, MODEL PVCN100
    K100462 JETSTREAM G3 L SYSTEM, PV CONSOLE, MODELS PV31400, PV31300, PVCN100
    K093918 JETSTREAM G3 L SYSTEM MODEL PV31400 (JETSTREAM G3 L CATHETER WITH CONTROL POD); PVCN100 (PV CONSOLE)
    K093456 JETSTREAM G3 SYSTEM
    K092332 JETSTREAM G3 SYSTEM, MODEL PV31300 ( JETSTREAM G3 CATHETER AND CONTROL POD)., PVCN100 (PV CONSOLE)
    K091509 JETSTREAM G2 NXT SYSTEM, MODEL PV20300
    K090325 JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD); PVCN100 (PV CONSOLE)
    Search all 16 clearances from PATHWAY MEDICAL TECHNOLOGIES, INC. →