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

    BIOSENSE WEBSTER PATIENT CABLE AND LEADWIRES

    K Number: K001390 · Decision Jul 21, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    139
    Registration Numbers
    139
    Same Product Code
    104
    Applicant Total
    73
    Review Days
    80

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    Basic Information

    Device Name
    BIOSENSE WEBSTER PATIENT CABLE AND LEADWIRES
    K Number
    K001390
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    870.2900
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biosense Webster, Inc.
    Date Received
    May 2, 2000
    Decision Date
    July 21, 2000
    Product Code
    DSA
    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
    DSA Cable, Transducer And Electrode, Patient, (Including Connector)

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    Other Clearances by Biosense Webster, Inc.

    K Number Device Name
    K252972 CARTO™ 3 EP Navigation System V8.4
    K254085 CARTO™ 3 EP Navigation System V9.0 with PIU Plus
    K252302 CARTO™ 3 EP Navigation System V8.1
    K241540 NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound Catheter
    K240050 SOUNDSTAR™ CRYSTAL Ultrasound Catheter
    K231207 CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)
    K231312 PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto ID
    K231412 CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S)
    K230253 OPTRELL™ Mapping Catheter with TRUEref™ Technology
    K223766 NUVISION™ NAV Ultrasound Catheter
    Search all 73 clearances from Biosense Webster, Inc. →