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

    Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva

    K Number: K231401 · Decision Sep 21, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    6
    Review Days
    129

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    Basic Information

    Device Name
    Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva
    K Number
    K231401
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Poly Medicure Limited
    Date Received
    May 15, 2023
    Decision Date
    September 21, 2023
    Product Code
    FOZ
    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
    FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

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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
    K230616 Polyguard and Polyshield Safety IV Catheters
    K220312 Polyfusion IV Administration Sets