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

    MAHURKAR OPLUS CATHETER, MODEL 13.5 FR

    K Number: K030209 · Decision May 13, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    36
    Applicant Total
    8
    Review Days
    112

    Basic Information

    Device Name
    MAHURKAR OPLUS CATHETER, MODEL 13.5 FR
    K Number
    K030209
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    THE KENDALL COMPANY
    Date Received
    January 21, 2003
    Decision Date
    May 13, 2003
    Product Code
    MPB
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MPB Catheter, Hemodialysis, Non-Implanted

    Similar 510(k) Clearances

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

    Acute Dual Lumen Hemodialysis Catheter

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Duo-Flow Side x Side Double Lumen Catheter

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Zenysis Short-Term Dialysis Catheter

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Zenysis Short-Term Dialysis Catheter

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by THE KENDALL COMPANY

    K Number Device Name
    K061936 KENDALL ARGYLE NEONATAL/PEDIATRIC PICC, MODEL 43311
    K020089 MAHURKAR TRIPLE LUMEN CATHETER, 12 FR
    K011283 MONOJECT PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE
    K011941 EXCILON AMD ANTIMICROBIAL SPONGE MODEL #7088
    K002902 TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERS
    K002901 KENDALL 14.5 FR MAXID CUFFED DUAL LUMEN CATHETER
    K003313 FILAC FAS TEMP ELECTRONIC THERMOMETER