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

    PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES

    K Number: K945777 · Decision Dec 22, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    230
    Applicant Total
    22
    Review Days
    27

    Basic Information

    Device Name
    PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES
    K Number
    K945777
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1675
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
    Date Received
    November 25, 1994
    Decision Date
    December 22, 1994
    Product Code
    JKA
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

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    Other Clearances by SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.

    K Number Device Name
    K972385 FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED
    K965017 REGIONAL ANESTHESIA TRAYS
    K962175 PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE
    K962931 SIMS PRO-VENT 250 (500) PLUS ARTERIAL BLOOD SAMPLING KIT
    K963570 SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22)
    K960429 PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT W/PORTEX TRACHEOSTMY TUBE & DISP. INNER CANNULA
    K953485 SIMS CPAP SYSTEM
    K953483 SIMS BLUE LINE ENDOBRONCHIAL TUBE
    K932946 WALLACE IV CANNULA
    K932947 WALLACE Y-CAN
    Search all 22 clearances from SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. →