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

    LIVEWIRE ELECTOPHYSIOLOGY CATHETER

    K Number: K102721 · Decision Oct 18, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    184
    Applicant Total
    105
    Review Days
    27

    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
    LIVEWIRE ELECTOPHYSIOLOGY CATHETER
    K Number
    K102721
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1220
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    St Jude Medical
    Date Received
    September 21, 2010
    Decision Date
    October 18, 2010
    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 St Jude Medical

    K Number Device Name
    K181382 GuardianTM Burr Hole Cover System
    K172396 EnSite Velocity Cardiac Mapping System v5.2
    K173232 myMerlin(TM) Mobile Application Model APP1001
    K160335 Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D
    K160218 AutoMark Module
    K162643 MediGuide Technology System
    K160210 EnSite Precision Cardiac Mapping System v2.0
    K161873 Pacel Flow Directed Pacing Catheter
    K160187 Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0
    K160186 EnSite Velocity Surface Electrode Kit
    Search all 105 clearances from St Jude Medical →