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

    MANAN ARTERIAL CATHETER NEEDLE

    K Number: K900978 · Decision Aug 23, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    276
    Registration Numbers
    277
    Same Product Code
    889
    Applicant Total
    39
    Review Days
    174

    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
    MANAN ARTERIAL CATHETER NEEDLE
    K Number
    K900978
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Manan Medical Products, Inc.
    Date Received
    March 2, 1990
    Decision Date
    August 23, 1990
    Product Code
    DQY
    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
    DQY Catheter, Percutaneous

    Similar 510(k) Clearances

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

    Amplatzer TorqVue Exchange System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Perfect-O Ostial Positioning Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Amplatzer TorqVue Delivery System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Teleport Glide Microcatheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Manan Medical Products, Inc.

    K Number Device Name
    K052802 MANAN BIO-CUT SOFT TISSUE BIOPSY NEEDLE
    K011209 MANAN SPRITACRE SPINAL NEEDLES
    K983620 MANAN SPINAL NEEDLES
    K980536 EPIDURAL NEEDLE
    K981386 MANAN BLUNT NEEDLE
    K980211 MRI CHIBA,SPINAL,BREAST LOCALIZATION,AUTOMATIC CUTTING NEEDLES
    K974446 MANAN AUTOMATIC CUTTING NEEDLE
    K962977 MRI COMPATIBLE BIOPSY NEEDLES
    K963767 MANAN V.S. ACCESS NEEDLE/SET
    K961986 MANAN D BAG
    Search all 39 clearances from Manan Medical Products, Inc. →