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

    PRO-VENT, PULSATOR ARTERIAL BLOOD SAMPLING SYRINGES

    K Number: K981035 · Decision Apr 21, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    218
    Registration Numbers
    218
    Same Product Code
    235
    Applicant Total
    12
    Review Days
    33

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    Basic Information

    Device Name
    PRO-VENT, PULSATOR ARTERIAL BLOOD SAMPLING SYRINGES
    K Number
    K981035
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1675
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sims Portex, Inc.
    Date Received
    March 19, 1998
    Decision Date
    April 21, 1998
    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 Sims Portex, Inc.

    K Number Device Name
    K011925 HYPODERMIC NEEDLE-PRO NEEDLE WITH NEEDLE PROTECTION DEVICE; HYPODERMIC NEEDLE-PRO SYRINGE & NEEDLE WITH NEEDLE PROTECTIO
    K002201 ELECTROSTATIC HYDROPHOBIC BREATHING FILTER
    K002506 BREATHING FILTER FOR DISPOSABLE ANESTHESIA BREATHING CIRCUIT
    K001318 CPAP SYSTEM, MODEL 102001
    K993619 CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCK
    K994275 SIMS PORTEX ANESTHESIA CATHETER
    K991861 1ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST RESPONSE PEDIATRIC MANUAL RESUSCITATOR, BAG RESERVOIR, 1ST RE
    K992471 SIMS PORTEX EPIDURAL CATHETER, 20G MODEL# 4910-16/17; 21G MODEL# 4910-18
    K992057 IST RESPONSE MANUAL RESUSCITATOR, MODELS, 008000, 008003,008006
    K983858 SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLES
    Search all 12 clearances from Sims Portex, Inc. →