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

    I.V. STARTPAK VASCULAR ACCESS START KIT

    K Number: K942238 · Decision Jun 3, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    68
    Same Product Code
    29
    Applicant Total
    632
    Review Days
    25

    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
    I.V. STARTPAK VASCULAR ACCESS START KIT
    K Number
    K942238
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bd Becton Dickinson Vacutainer Systems Preanalytic
    Date Received
    May 9, 1994
    Decision Date
    June 3, 1994
    Product Code
    LRS
    Advisory Committee
    General Hospital
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LRS I.V. Start Kit

    Similar 510(k) Clearances

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

    AMSINO I.V. START KIT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    INFUSION IV SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    IV START KIT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    EMS I.V. START KIT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    B. BRAUN IV START KITS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PERSONAL HEARING SYSTEM

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

    Other Clearances by Bd Becton Dickinson Vacutainer Systems Preanalytic

    K Number Device Name
    K003062 BACTEC MGIT 960 SIR KITS
    K003553 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE
    K003461 BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE
    K002938 B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16
    K001364 BD DIRECTIGEN FLU A+B
    K000762 MOXIFLOXACIN, 5 UG, BBL SENSI-DISC
    K000829 GATIFLOXACIN, 5 UG, BBL SENSI-DISC
    K993186 SYNERCID, 15 UG, BBL SENSI-DISC
    K992734 BECTON DICKINSON SYRINGE
    K991551 VACUTAINER BRAND SODIUM CITRATE PEDIATRIC TUBE
    Search all 632 clearances from Bd Becton Dickinson Vacutainer Systems Preanalytic →