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

    REPROCESSED ELECTROPHYSIOLOGY CATHETERS

    K Number: K061045 · Decision Aug 31, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    69
    Applicant Total
    36
    Review Days
    139

    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
    REPROCESSED ELECTROPHYSIOLOGY CATHETERS
    K Number
    K061045
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1220
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alliance Medical Corp.
    Date Received
    April 14, 2006
    Decision Date
    August 31, 2006
    Product Code
    NLH
    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
    NLH Catheter, Recording, Electrode, Reprocessed

    Similar 510(k) Clearances

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

    Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID Technology (BD710DF282CT, BD710DF282RTS, BD710FJ282RTS, BD710FJ282CT)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter, Supreme Electrophysiology Catheter (401150, 401206, 401207, 401210, 401211, 401212, 401222, 401223, 401226, 401227, 401228, 401260, 401261, 401271, 401305, 401306, 401309, 401310, 401311, 401312, 401317, 401353, 401357, 401381, 401392, 401399, 401400, 401425, 401430, 401433, 401434, 401435, 401436, 401438, 401441, 401442, 401443, 401444, 401445, 401448, 401449, 401450, 401451, 401453, 401466, 401468, 401

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

    Other Clearances by Alliance Medical Corp.

    K Number Device Name
    K060648 REPROCESSED PHACOEMULSIFICATION TIPS
    K060049 REPROCESSED COMPRESSION SLEEVES
    K060091 ALLIANCE MEDICAL CORPORATION REPROCESSED COMPRESSION SLEEVES
    K053316 REPROCESSED COMPRESSION SLEEVES
    K052918 REPROCESSED EXTERNAL FIXATION DEVICES
    K052603 REPROCESSED DAIG LIVEWIRE ELECTROPHYSIOLOGY CATHETERS
    K052414 REPROCESSED ELECTROPHYSIOLOGY CATHETER
    K052064 ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES
    K052062 ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES
    K052065 ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES
    Search all 36 clearances from Alliance Medical Corp. →