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

    REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER

    K Number: K100254 · Decision May 28, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    69
    Applicant Total
    21
    Review Days
    120

    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 CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER
    K Number
    K100254
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1220
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ascent Healthcare Solutions
    Date Received
    January 28, 2010
    Decision Date
    May 28, 2010
    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 Ascent Healthcare Solutions

    K Number Device Name
    K111600 REPROCESSED HAND ACTIVATE SEALER/DIVIDER
    K110189 REPROCESSED ELECTROSURGICAL INSTRUMENT
    K100909 REPROCESSED COMPRESSION SLEEVES
    K100537 REPROCESSED ULTRASONIC CURVED SHEARS WITH TORQUE WRENCH AND GRIP ASSIST MODEL FCS9, TWBLUE, GABLUE
    K100080 REPROCESSED TROCARS, MODEL B5LT AND CB5LT
    K093702 REPROCESSED ULTRASONIC COAGULATING SHEARS
    K092425 REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETERS, MODEL SNDSTR10
    K090323 REPROCESSED ELECTROPHYSIOLOGY CATHETERS
    K082023 REPROCESSED ELECTROPHYSIOLOGY CATHETERS
    K081238 REPROCESSED MASIMO PULSE OXIMETER SENSORS
    Search all 21 clearances from Ascent Healthcare Solutions →