BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    BD INTROSYTE PRECISION INTRODUCER, BD INTROSYTE AUTOGAURD SHIELDED INTRODUCER

    K Number: K013304 · Decision Jan 2, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    5
    Applicant Total
    36
    Review Days
    90

    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
    BD INTROSYTE PRECISION INTRODUCER, BD INTROSYTE AUTOGAURD SHIELDED INTRODUCER
    K Number
    K013304
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.5520
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Becton Dickinson Infusion Therapy Systems, Inc.
    Date Received
    October 4, 2001
    Decision Date
    January 2, 2002
    Product Code
    DBY
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DBY Fab, Rhodamine, Antigen, Antiserum, Control

    Similar 510(k) Clearances

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

    CONVOY ADVANCED DELIVERY SHEATH

    FDA 510(k)
    FDA Class 1 ·Immunology

    TORFLEX TRANSSEPTAL GUIDING SHEATH

    FDA 510(k)
    FDA Class 1 ·Immunology

    CONVOY ADVANCED DELIVERY SHEATH KIT

    FDA 510(k)
    FDA Class 1 ·Immunology

    GORE INTRODUCER SHEATH

    FDA 510(k)
    FDA Class 1 ·Immunology

    RHODAMINE-CONJUGATED ANTISERUM

    FDA 510(k)
    FDA Class 1 ·Immunology
    View all

    Other Clearances by Becton Dickinson Infusion Therapy Systems, Inc.

    K Number Device Name
    K252137 BD Insyte™ IV Catheter
    K251422 BD Saf-T-Intima™ Subcutaneous Catheter System
    K243403 BD Nexiva™ Closed IV Catheter System
    K251155 BD Cathena™ Safety IV Catheter
    K251654 BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter
    K250682 BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector
    K241586 PIVO™ Pro Needle-free Blood Collection Device
    K233529 BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector
    K230865 PIVO™ Pro Needle-free Blood Collection Device
    K231239 Nexiva™ Closed IV Catheter System with NearPort™ IV Access
    Search all 36 clearances from Becton Dickinson Infusion Therapy Systems, Inc. →