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

    PATHFINDER 3MM MAPPING MICROCATHETER (01-082001)

    K Number: K970853 · Decision Nov 4, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    184
    Applicant Total
    12
    Review Days
    242

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    PATHFINDER 3MM MAPPING MICROCATHETER (01-082001)
    K Number
    K970853
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1220
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cardima, Inc.
    Date Received
    March 7, 1997
    Decision Date
    November 4, 1997
    Product Code
    DRF
    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
    DRF Catheter, Electrode Recording, Or Probe, Electrode Recording

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (DRF), ordered by most recent decision date.

    Vision-MR™ Diagnostic Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MAGiC Sweep™ EP Mapping Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VIKING™ Fixed Curve Diagnostic Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic XT™ Unidirectional Steerable Diagnostic Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Nordica PV Cryo Mapping Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Cosine-10TM Diagnostic Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Cardima, Inc.

    K Number Device Name
    K060715 MODIFICATION TO: CARDIMA ABLATION SYSTEM
    K022008 CARDIMA ABLATION SYSTEM
    K974683 NAVIPORT DEFLECTABLE TIP GUIDING CATHETER
    K972803 TRACER O-T-W MAPPING DEVICE
    K982835 ELECTRODE SWITCHBOX, MODEL 11-081002
    K971975 CARDIMA PATHFINDER 1.5F MAPPING MICROCATHETER
    K973298 CARDIMA VUEPORT CORONARY SINUS BALLOON OCCLUSION GUIDING CATHETER
    K955802 PATHFINDER
    K951603 CARDIMA, INC. FORERUNNER
    K932800 CARDIMA TRACKER(R) INFUSION CATHETER
    Search all 12 clearances from Cardima, Inc. →