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

    VITALCARE I.V. ADMINISTRATION SET

    K Number: K050906 · Decision Aug 23, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    424
    Registration Numbers
    424
    Same Product Code
    1173
    Applicant Total
    8
    Review Days
    134

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    Basic Information

    Device Name
    VITALCARE I.V. ADMINISTRATION SET
    K Number
    K050906
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vitalcare Group, Inc.
    Date Received
    April 11, 2005
    Decision Date
    August 23, 2005
    Product Code
    FPA
    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
    FPA Set, Administration, Intravascular

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    Other Clearances by Vitalcare Group, Inc.

    K Number Device Name
    K060109 OMI RETRACTABLE SAFETY SYRINGE
    K040916 VITALCARE POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVE
    K031748 VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGES
    K992289 VINYL POWDERED EXAM GLOVE / CAT.# 15-020
    K983016 GAUZE, SPONGES, CAT # 11-003
    K983716 VITALCARE DISPOSABLE VAGINAL SPECULUM
    K982901 LATEX PATIENT EXAMINATION GLOVE, CAT. NO. 1000M POWDERED