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510(k) Data Aggregation

    K Number
    K970938
    Device Name
    HUNTER 0.014 INCH SUPER SOFT / HUNTER O.014 INCH SOFT GUIDE WIRES W/THROMBORESISTANT PC COATING
    Date Cleared
    1997-11-17

    (249 days)

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

    BIOCOMPATIBLES CARDIOVASCULAR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Hunter™ Super Soft and Soft guide wires with phosphorylcholine (PC) coating are intended to facilitate the placement of PTA and/or PTCA balloon catheters within the peripheral and coronary vasculature. This guide wire is 0.014-inch size and designed for safe use within appropriately sized balloon catheters. This device is not for use in the cerebral vasculature.
    Device Description
    The Hunter guide wires are coated with a high molecular weight phosphorvicholine ("PC") polymer. The core wire and spring coils are coated with phosphorylcholine (PC). The PC coating aids in the prevention of thrombus formation on the guide wire tip during short-term clinical use. While the PC coating has been shown to resist thrombus accumulation during PTCA procedures, a clinical significance of this reduction has not been demonstrated. The guide wires are full-length core wire design having a distal 30cm long spring coil. PC-coated guide wires are available in 175cm and 300cm lengths with distal radiopaque platinum/fungsten spring coil lengths of 4cm and 30cm.
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    K Number
    K962717
    Device Name
    6 FRENCH, 7 FRENCH, AND 8 FRENCH GUIDING CATHETERS WITH PHOSPHORYLCHOLINE (PC) POLYMER COATING
    Date Cleared
    1997-02-12

    (215 days)

    Product Code
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOCOMPATIBLES CARDIOVASCULAR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Guiding Catheters with PC Polymer Coating are indicated to aid the percutaneous placement of guide wires, balloon dilatation catheters, and other devices required for peripheral and coronary artery transcatheter diagnosis and therapy. The guiding catheters are not intended for use in the cerebral vasculature.
    Device Description
    The 6 Fr, 7 Fr, and 8 Fr Guiding Catheters with PC Polymer Coating have shaft nominal outside diameters of 0.079", 0.092", and 0.104" with nominal inside diameters of 0.064", 0.075", and 0.087", respectively. The guiding catheters are available in lengths of 65 cm, 85 cm, 100 cm, and 110 cm. Distal side holes and different curve styles are available. The inner and outer surfaces of the guiding catheter are coated with a hydrophilic polymer. The catheter hub is disk shaped and injection molded onto the shaft. The shaft is an extruded thermoplastic with an embedded stainless steel braided wire extending from the hub to the radiopaque tip. A hub-to-shaft kink protector is included. The tip is made of a low durometer radiopaque thermoplastic and is heat welded to the end of the catheter shaft. The guiding catheters are packaged in Tyvek/Mylar heat sealed sterilization pouches and gas sterilized by ethylene oxide.
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    K Number
    K962266
    Device Name
    0.014 INCH EXTRA LONG FLOPPY AND 0.014 EXTRA LONG INTERMEDIATE GUIDE WIRES WITH PHOSPHORYLCHOLINE (PC) POLYMER COATING
    Date Cleared
    1996-09-10

    (90 days)

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

    BIOCOMPATIBLES CARDIOVASCULAR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Floppy and Intermediate Extra Long 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 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 (2) and Intermediate (2) Extra Long Guide Wires have a nominal outside diameter of 0.014 inch measured at the distal spring coil. The guide wires are 300 cm (nominal) in length and have a distally attached 30 cm composite spring coil. For the 30 cm radiopaque guide wires, the entire spring coil is made of platinum/tungsten alloy. The spring coil of the 4 cm radiopaque guide wires is proximally made of stainless steel wire (26 cm) and has a distal platinum/tungsten alloy spring coil for opacity. For all guide wires, the core wire and spring coils, up to and including the tip, are coated with phosphoryIcholine polymer.
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