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

    BD CAREFLOW CENTRAL VENOUS CATHETER

    K Number: K033500 · Decision Jan 29, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    190
    Review Days
    85

    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 CAREFLOW CENTRAL VENOUS CATHETER
    K Number
    K033500
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Becton, Dickinson & CO
    Date Received
    November 5, 2003
    Decision Date
    January 29, 2004
    Product Code
    FOZ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

    Similar 510(k) Clearances

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

    Introcan Safety® Deep Access XL IV Catheter

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD Insyte™ IV Catheter

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SURFLO Hybria Closed System Safety IV Catheter

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Polyshield Safety IV Catheters

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD Saf-T-Intima™ Subcutaneous Catheter System

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by Becton, Dickinson & CO

    K Number Device Name
    K160164 BD Veritor System for Rapid Detection of Flu A + B Labratory Kit
    K160161 BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit
    K141474 BECTON DICKINSON INTELLIPORT SYSTEM
    K140446 BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY
    K140448 BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY
    K140591 BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - INJECTOR
    K133140 BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV
    K133138 BD Veritor™ System Flu A+B Assay
    K130268 BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAY
    K131301 BD FACS SAMPLE PREP ASSISTANT III
    Search all 190 clearances from Becton, Dickinson & CO →