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510(k) Data Aggregation

    K Number
    K153264
    Device Name
    EasyPass Guidewire
    Manufacturer
    MEDI-GLOBE CORPORATION
    Date Cleared
    2016-05-19

    (189 days)

    Product Code
    OCY
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    OCY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EasyPass Guidewire is used for selective cannulation of the biliary ducts including, but not limited to the common bile duct, cystic duct, and right and left hepatic ducts. The EasyPass guidewire is designed to be used during endoscopic biliary procedures for catheter introduction and exchanges.
    Device Description
    The EasyPass Guidewire consists of a Nitinol core wire with a proximal 2-color spiral patterned PTFE jacket and a copolymer distal section. The distal stainless steel spring section of the guidewire provides flexibility and incorporates a hydrophilic coating. The EasyPass Guidewire is a sterile packed, disposable instrument intended for single-patient use only.
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    K Number
    K151471
    Device Name
    Radifocus Glidewire Endoscopic Wire
    Manufacturer
    Terumo Medical Corporation
    Date Cleared
    2015-09-17

    (108 days)

    Product Code
    OCY
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    OCY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Radifocus Glidewire Endoscopic Wire is intended to be used for selective cannulation of the biliary ducts, including but not limited to, the common bile, cystic, right and left hepatic ducts during endoscopic biliary procedures for catheter introduction and exchanges.
    Device Description
    The Radifocus Glidewire Endoscopic Wire is an endoscopic guide wire that is provided sterile and is intended for single use only. It consists of a Nickel Titanium alloy core wire, and a polyurethane containing tungsten and hydrophilic polymer that are applied to the entire wire. There are two shaft configurations: standard and stiff; the stiff shaft has a slightly thicker core wire than that of the standard shaft. The wire distal segment comes in angled or straight configurations and is packaged in a plastic holder that is contained within an individual package. A guide wire inserter is contained within the individual package to assist with the insertion of the wire into an endoscope or catheter.
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    K Number
    K150927
    Device Name
    Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire straight stiff, Orchestra Hydrophilic Guidewire angled stiff,Orchestra Hydrophilic Guidewire standard straight, Orchestra Hydrophilic Guidewire straight stiff
    Manufacturer
    COLOPLAST A/S
    Date Cleared
    2015-05-27

    (51 days)

    Product Code
    OCY
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    OCY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The hydrophilic guidewire is intended to facilitate the placement of devices through the urinary tract during endourologic procedures.
    Device Description
    The Orchestra® Hydrophilic Guidewire is a guidewire consisting of a metallic core wire with a polymer coating. A hydrophilic coating is applied over the radiopaque polymer jacket. The guidewire is supplied sterile and non-pyrogenic.
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    K Number
    K150225
    Device Name
    NovaGold High Performance Guidewire
    Manufacturer
    NEOMETRICS, INC.
    Date Cleared
    2015-03-16

    (42 days)

    Product Code
    OCY
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    OCY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NovaGold Guidewire is intended for use in selective cannulation of the billary ducts including the common bile, pancreatic, cystic, right and left hepatic ducts, and to aid in the placement of diagnostic devices during endoscopic procedures.
    Device Description
    The NovaGold Guidewire is constructed from a steerable, metallic core with a PTFE polymer coating over the shaft. A hydrophilic coating is applied over the distal portion of the device. The guidewire has a radiopaque, floppy tip.
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    K Number
    K142950
    Device Name
    Acrobat Calibrated Tip Wire Guide
    Manufacturer
    Wilson-Cook Medical, Inc
    Date Cleared
    2014-11-05

    (26 days)

    Product Code
    OCY
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    OCY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to assist in cannulation of the biliary and pancreatic ducts and to aid in bridging difficult strictures during ERCP.
    Device Description
    The Acrobat Calibrated Tip Wire Guide is a modification to the existing Endoscopic Wire Guides currently marketed by Wilson-Cook Medical, Inc. The modified wire guide is compatible with a .025", .035" inch or larger inner diameter accessory and available in 205cm, 260cm and 450cm lengths. The wire guide features include marks at 5cm to 25cm at the distal end that provide reference points to indicate movement of wire guide while in use. The distal tip consists of an 11.5cm or 27cm hydrophilic slip-coating.
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    K Number
    K141820
    Device Name
    JAGWIRE HIGH PERFORMANCE GUIDWIRE
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Date Cleared
    2014-10-21

    (106 days)

    Product Code
    OCY
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    OCY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indicated for use in selective cannulation of the biliary ducts including, but not limited to the common bile, cystic, right and left hepatic ducts. The guidewires are designed to be used during endoscopic biliary procedures for catheter introduction and exchanges. The Jagtail™ High Performance Guidewire Extension attached to the extendable Jagwire™ 260 cm Guidewire is designed for use during endoscopic biliary procedures for non-rapid exchange catheter introduction and exchanges. The attachment of the Jagtail High Performance Guidewire Extension to the extendable Jagwire 260 cm guidewire creates an extended guidewire that can be used to exchange out a non-rapid exchange biliary catheter without removing the original guidewire from the associated duct. When the exchange is completed, the Jagtail High Performance Guidewire Extension can be detached and the original, extendable Jagwire 260 cm guidewire can be used in a conventional manner.
    Device Description
    Jagwire™ High Performance Guidewire, and Jagwire™ High Performance Extendable Guidewire: The Boston Scientific Jagwire™ High Performance Guidewire is constructed of a metal alloy core, which is encapsulated in a striped PTFE jacket with a 5 cm hydrophilic radiopaque distal tip. The striped jacket provides endoscopically visible movement markings. Jagtail™ High Performance Guidewire Extension: The Boston Scientific Jagtail™ High Performance Guidewire Extension is a 200 cm long guidewire extension constructed of a stainless steel core with a connector at the distal end. The shaft is coated with a PTFE sleeve. The Jagtail High Performance Guidewire Extension is exclusively compatible with the Jagwire High Performance Extendable Guidewire, 260 cm. The distal end of the Jagtail High Performance Guidewire Extension is inserted into the proximal end of the extendable Jagwire 260 cm guidewire with the use of the alignment tool. The alignment tool is then removed from the Jagtail High Performance Guidewire Extension.
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    K Number
    K142397
    Device Name
    Predicate III Guidewire
    Manufacturer
    Lake Region Medical
    Date Cleared
    2014-09-19

    (23 days)

    Product Code
    OCY
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    OCY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To facilitate the introduction of other diagnostic and treatment devices used in gastroenterology and urology procedures.
    Device Description
    The guidewire is made of an uncoated Nitinol or Stainless Steel core wire that is tapered at the distal tip where a coil is secured over the core. The wire can have a distal coil or a full length coil that is made of Stainless Steel. The guidewire may contain proximal markers. The PREDICATE™ III GUIDEWIRE family is bound by the following parameters: Lengths: 30cm – 500cm, Outside Diameter: 0.018" to 0.038", Tips: Straight or Shaped with various flexibilities, Coil Length: Full length, 2cm to 30cm.
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    K Number
    K140482
    Device Name
    MANDREL GUIDEWIRE
    Manufacturer
    LAKE REGION MEDICAL
    Date Cleared
    2014-04-08

    (41 days)

    Product Code
    OCY
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    OCY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Mandrel Guidewires are intended to facilitate the introduction of other diagnostic and treatment devices used in gastroenterology and urology procedures.
    Device Description
    The Mandrel wire family is made of a coated (PTFE or Silicone) or uncoated Nitinol or Stainless Steel core wire that is tapered at the distal tip where a coil is secured to the distal end. The distal coil can be anywhere from 2cm to 30cm depending on specific design and can consist of Stainless Steel, Palladium, Platinum, or the proposed Tungsten materials. The guidewire may contain proximal core markers. The Mandrel guidewire family is bound by the following parameters: Lengths: 20cm to 500cm, Outside Diameter: 0.014" To 0.35", Tips: Straight or shaped with various flexibilities, Coil Length: 2cm to 30cm.
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    K Number
    K133076
    Device Name
    NOVAGOLD HIGH PERFORMANCE GUIDEWIRE
    Manufacturer
    NEOMETRICS, INC.
    Date Cleared
    2014-02-20

    (143 days)

    Product Code
    OCY
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    OCY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NovaGold Guidewire is intended for use in selective cannulation of the biliary ducts including the common bile, pancreatic, cystic, right and left hepatic ducts, and to aid in the placement of diagnostic and therapeutic devices during endoscopic procedures.
    Device Description
    The NovaGold Guidewire is constructed from a steerable, metallic core with a PTFE polymer coating over the shaft. A hydrophilic coating is applied over the distal portion of the device. The guidewire has a radiopaque, floppy tip.
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    K Number
    K131072
    Device Name
    ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE STRAIGHT STIFF, ORCHESTRA HYDROPHILIC
    Manufacturer
    COLOPLAST A/S
    Date Cleared
    2013-07-09

    (83 days)

    Product Code
    OCY
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    OCY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The hydrophilic guidewire is intended to facilitate the placement of devices through the urinary tract during endourologic procedures.
    Device Description
    The Orchestra® Hydrophilic Guide Wire is a guidewire consisting of a metallic core wire with a polymer coating. A hydrophilic coating is applied over the radiopaque polymer jacket. The guidewire is supplied sterile and non-pyrogenic.
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