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

    PUNCTURE KIT, INTERNAL JUGULAR

    K Number: K770462 · Decision Mar 14, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    210
    Registration Numbers
    211
    Same Product Code
    499
    Applicant Total
    110
    Review Days
    5

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    Basic Information

    Device Name
    PUNCTURE KIT, INTERNAL JUGULAR
    K Number
    K770462
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Arrow Intl., Inc.
    Date Received
    March 9, 1977
    Decision Date
    March 14, 1977
    Product Code
    DQO
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DQO Catheter, Intravascular, Diagnostic

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    Other Clearances by Arrow Intl., Inc.

    K Number Device Name
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    K093050 ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520
    K071491 ARROW INTERNATIONAL, INC., SURGICAL DRAPES
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    K071111 NON-ABSORBABLE SILK SUTURE
    K060309 AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES
    K042126 PICC
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    K040802 HEMOSONIC 200HEMODYNAMIC MONITOR
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