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

    NU-CATH EMERGENCY KIT

    K Number: K850398 · Decision Mar 27, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    12
    Review Days
    54

    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
    NU-CATH EMERGENCY KIT
    K Number
    K850398
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Intl. Medical Devices , Ltd.
    Date Received
    February 1, 1985
    Decision Date
    March 27, 1985
    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 Intl. Medical Devices , Ltd.

    K Number Device Name
    K913540 PEDIA-THOR THORACOSTOMY KIT
    K913541 NEO-THOR THORACOSTOMY KIT
    K913539 THORACIC CATHTER STYLET
    K913542 THORACIC CATHETER WITH GUIDE
    K913543 THORACIC CATHETER STYLET
    K862909 RE-TRAKE WEISS EMERGENCY AIRWAY & THORACIC SYSTEM
    K843785 WISSS PEDIATRIC TRACH- TUBE W/OBTURATOR
    K842666 NU-THOR THORACOSTOMY KIT
    K840925 PEDIA-TRAKE CRICOTHYROTOMY KIT
    K820778 RESPIRATION MONITOR 1000
    Search all 12 clearances from Intl. Medical Devices , Ltd. →