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

    SUBCUTANEOUS TUNNELING NEEDLE AND HANDLES

    K Number: K930218 · Decision Jul 27, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    5
    Applicant Total
    23
    Review Days
    193

    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
    SUBCUTANEOUS TUNNELING NEEDLE AND HANDLES
    K Number
    K930218
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5120
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Concord/Portex
    Date Received
    January 15, 1993
    Decision Date
    July 27, 1993
    Product Code
    MAJ
    Advisory Committee
    Anesthesiology
    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
    MAJ Catheter, Percutaneous, Intraspinal, Short Term

    Similar 510(k) Clearances

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

    MEDTRONIC ALGOLINE INTRASPINAL CATHETER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MEDTRONIC MODEL 3864C & 3865C TEMPORARY SCREENING LEAD/CATHETER KIT

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    TEMPORARY SCREENING LEAD/ CATHETER KIT

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    IPI ALGO-LINE CATHETER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    LIFECARE CONT. EPIDURAL CATH. FOR MORPHINE SULFATE

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

    Other Clearances by Concord/Portex

    K Number Device Name
    K923559 STERI-CATH MDI
    K924541 EPIDURAL MINIPACK
    K930286 DRI-VENDT/PROVENT/ACCUVENT ARTERIAL BLOOD GAS KITS
    K923127 NEEDLE-PRO CARTRIDGE
    K923910 HEAT MOISTURE CONDENSER
    K922749 LOW PROFILE TRACHEOSTOMY TUBE
    K922445 VACU-PRO
    K915452 ANESTHESIA BREATHING CIRCUIT
    K911809 NEW-VENT
    K912124 TRACHEOSTOMY TUBE AND CUFF
    Search all 23 clearances from Concord/Portex →