BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇳 India

    Polyfusion IV Administration Sets

    K Number: K220312 · Decision Apr 12, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    424
    Registration Numbers
    424
    Same Product Code
    1173
    Applicant Total
    6
    Review Days
    434

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    Basic Information

    Device Name
    Polyfusion IV Administration Sets
    K Number
    K220312
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Poly Medicure Limited
    Date Received
    February 2, 2022
    Decision Date
    April 12, 2023
    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 Poly Medicure Limited

    K Number Device Name
    K252513 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)
    K252677 Polyshield Safety IV Catheters
    K232234 Nouvo Safety Set
    K231401 Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva
    K230616 Polyguard and Polyshield Safety IV Catheters