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

    VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS

    K Number: K050763 · Decision Jun 1, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    69
    Applicant Total
    33
    Review Days
    69

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    Basic Information

    Device Name
    VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
    K Number
    K050763
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1220
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vanguard Medical Concepts, Inc.
    Date Received
    March 24, 2005
    Decision Date
    June 1, 2005
    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

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    Other Clearances by Vanguard Medical Concepts, Inc.

    K Number Device Name
    K053051 VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES
    K051616 VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES
    K051180 VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES
    K051043 VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
    K043198 VANGUARD REPROCESSED ARTHROSCOPIC WANDS
    K043253 VANGUARD REPROCESSED DILATING TIP AND BLUNT TROCARS
    K043594 VANGUARD REPROCESSED BLADED TROCAR, NON-BLADED TROCAR, TROCAR ACCESSORIES
    K043225 VANGUARD REPROCESSED ULTRASONIC SCALPEL
    K043315 VANGUARD REPROCESSED HAND-ACTIVATED ULTRASONIC SCALPEL
    K040751 VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
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