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510(k) Data Aggregation

    K Number
    K961232
    Device Name
    0.014 FLOPPY & 0.014 INTERMEDIATE GUIDE WIRES W/PHOSPHORYLCHOLINE POLYMER COATING & 4CM RADIOPAQUE TIP
    Date Cleared
    1996-06-26

    (89 days)

    Product Code
    Regulation Number
    870.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOCOMPATIBLES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Floppy and Intermediate guide wires and predicate devices are intended for use to facilitate the placement of PTA and/or PTCA balloon dilatation catheters within the peripheral or coronary vasculature. The guide wires are designed for safe use with appropriately sized balloon catheters. The guide wires are not intended for use in the cerebral vasculature.
    Device Description
    The Floppy and Intermediate guide wires have a nominal outside diameter of 0.014 inch measured at the distal spring coil. The guide wires are 176 cm long (nominal) and have a distally attached 30 cm composite spring coil. The most distal 4 cm of the spring coil is radiopaque. The core wire and spring coils, up to and including the tip, are coated with PCP.
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    K Number
    K955135
    Device Name
    0.014 INTERMEDIATE GUIDE WIRE W/PHOSPHORYLCHOLINE POLYMER COATING
    Date Cleared
    1996-04-09

    (152 days)

    Product Code
    Regulation Number
    870.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOCOMPATIBLES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Floppy and Intermediate guide wires are intended for use to facilitate the placement of PTA and/or PTCA balloon dilatation catheters within the peripheral or coronary vasculature. The guide wires are a 0.014 inch size and designed for safe use with appropriately sized balloon catheters. The guide wires are not intended for use in the cerebral vasculature.
    Device Description
    The Floppy and Intermediate guide wires have a nominal outside diameter of 0.014 inch. The guide wires are 175 cm long (nominal) and have a 30 cm radiopaque spring coil joined distally to a central stainless steel core wire. The core wire and spring coils are coated with a hydrophilic phosphorvicholine polymer.
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