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510(k) Data Aggregation

    K Number
    K111606
    Device Name
    PINNACLE PRECISION ACCESS SYSTEM
    Manufacturer
    TERUMO MEDICAL CORP.
    Date Cleared
    2011-10-03

    (116 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    TERUMO MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pinnacle Precision Access System is used to facilitate placing a catheter through the skin into a vein or artery. The Entry Needle is an accessory device which is used to gain access to the vein or artery, for placement of the Mini Guide Wire. The Mini Guide Wire is an accessory device which is used for placement of the sheath into the vein or artery.
    Device Description
    The Pinnacle Precision Access System consists of an introducer sheath and a dilator which are packaged together with a metallic entry needle, a mini guide wire and a guide wire inserter, prior to sterilization. The Pinnacle Precision Access System is used to facilitate placing a catheter through the skin into a vein or artery. The sheath and dilator contain bismuth, making these devices visible under fluoroscopy The entry needle (cannula) is an accessory device which is used to gain access to the vein or artery for placement of the mini guide wire. The mini guide wire is an accessory device which is used for placement of the sheath and dilator into the vein or artery. The mini guide wire is offered in two versions, a stainless steel (spring coil) model and a Palladium tipped Nitinol model. A guide wire inserter is also provided to assist in insertion of the mini guide wire into the cannula.
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    K Number
    K111556
    Device Name
    GLIDECROSS SUPPORT CATHETER
    Manufacturer
    TERUMO MEDICAL CORP.
    Date Cleared
    2011-07-29

    (53 days)

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

    TERUMO MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GlideCross™ Support Catheter is intended to be used for guide wire support during access of the vasculature allowing for exchange of guide wires and provides for the delivery of saline and/or diagnostic contrast agents. The GlideCross™ Support Catheter is indicated for use in the peripheral vasculature.
    Device Description
    The GlideCross Support Catheters are single lumen intravascular catheters designed for use in the peripheral vasculature. The catheters provide support to guide wires during access of the vasculature and allow for exchange of guide wires while maintaining vessel access. The GlideCross Support Catheters are available in 9 models compatible with various guide wire sizes and have a lubricous hydrophilic coating on the distal shaft and a female Luer on the proximal end. The catheters have 3 encapsulated radiopaque marker bands evenly spaced along the distal shaft, with the distal band 3 mm from the tip, to aid in positioning of the catheter tip and in estimating distances.
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    K Number
    K110540
    Device Name
    TERUMO SUPPORT CATHETER
    Manufacturer
    TERUMO MEDICAL CORP.
    Date Cleared
    2011-05-13

    (77 days)

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

    TERUMO MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Terumo Support Catheters are intended to guide and support a guidewire during access of the vasculature, allow for wire exchanges and provide a conduit for the delivery of saline or diagnostic contrast agents.
    Device Description
    The Terumo Support Catheter is a three-layer construction comprised of a stainless steel braid sandwiched between two layers of polyester elastomer. The polyester elastomer contains tungsten for visibility and contrast under fluoroscopy in the distal portion of the catheter. The most distal tip contains no braid and the tip is available in either straight or curved shapes. The device has three radiopaque markers, the distal one is embedded in the tip wall while the more proximal two are swaged to the outer surface of the catheter. There is a hydrophilic coating on the distal portion of the catheter to enhance lubricity.
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    K Number
    K102008
    Device Name
    GLIDESHEATH
    Manufacturer
    TERUMO MEDICAL CORP.
    Date Cleared
    2010-07-21

    (5 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    TERUMO MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Glidesheath is used to facilitate placing a catheter through the skin into a vein or artery including but not limited to the radial artery. The Entry Needle is an accessory device which is used to gain access to the vein or artery including but not limited to the radial artery, for placement of the Mini Guide Wire. The Mini Guide Wire is an accessory device which is used for placement of the sheath into the vein or artery including but not limited to the radial artery.
    Device Description
    The Glidesheath is comprised of an introducer sheath and a dilator. The Glidesheath is coated with a hydrophilic coating to reduce the frictional resistance of the sheath when inserting or removing the sheath from the patient's blood vessel. The Sheath and Dilator contain bismuth, making these devices visible under fluoroscopy. The Glidesheath is used to facilitate placing a catheter through the skin into a vein or artery including but not limited to the radial artery. The Entry Needle is an accessory device which is used to gain access to the vein or artery including but not limited to the radial artery, for placement of the Mini Guide Wire. The Mini Guide Wire is an accessory device which is used for placement of the sheath into the vein or artery including but not limited to the radial artery. The Guide Inserter which is attached to the Mini Guide Wire holder is used to straighten out the wire. Accessories to the Glidesheath are the metal entry needle and the mini guide wire. Both the metal entry needle and the mini guide wire are packaged with the Glidesheath in a pouch prior to sterilization.
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    K Number
    K091329
    Device Name
    PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
    Manufacturer
    TERUMO MEDICAL CORP.
    Date Cleared
    2009-05-29

    (24 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    TERUMO MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pinnacle® Destination® Peripheral Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to lower extremity access via a contralateral approach.
    Device Description
    The Pinnacle® Destination® Peripheral Guiding Sheath is designed to perform as a guiding catheter and an introducer sheath. The Peripheral Guiding Sheath is packaged with the following components: a Sheath, a Dilator, a Hemostatic Valve, and a Dilator Retaining Clip (Devices with TBV Valve only).
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    K Number
    K082997
    Device Name
    TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER
    Manufacturer
    TERUMO MEDICAL CORP.
    Date Cleared
    2009-04-15

    (189 days)

    Product Code
    FOZ
    Regulation Number
    880.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    TERUMO MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TERUMO Hybria Closed System Safety I.V. Catheter is inserted into the patient's vascular system for short term use (<30 days) to withdraw blood samples, administer fluid intravenously, or monitor blood pressure by attaching a monitoring line. The needle shield feature and the needleless access port aids in the prevention of needle stick injuries. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy.
    Device Description
    The TERUMO® Hybria™ Closed System Safety I.V. Catheter is a device consisting of an over-the needle, peripheral intravascular catheter made of a slender, flexible, radio-opaque, plastic catheter, integrated extension tubing with a Y or I adaptor (needleless access port and/or filter cap available) and one touch clamp, and a passive needle-shielding mechanism. The design of the TERUMO® Hybria™ Safety I.V. catheter can be described as a closed system since it protects clinicians and patients from blood exposure during the catheter insertion procedures. Since the needle is withdrawn through a septum that seals after the needle has been removed and ports of the Y or I adapter attached to pre-connected tubing to the IV catheter are closed, blood remains within the TERUMO® Hybria™ Safety I.V. catheter during catheter insertion. The pressure exerted on the needle as it passes through the septum wipes blood from the needle, further reducing potential blood exposure. The one touch clamp on the integrated extension tubing is provided to minimize blood exposure when connecting with an infusion set.
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    K Number
    K090040
    Device Name
    RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP)
    Manufacturer
    TERUMO MEDICAL CORP.
    Date Cleared
    2009-02-06

    (31 days)

    Product Code
    DQO
    Regulation Number
    870.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    TERUMO MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP) is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the vascular system. It is also used to lead a guide wire or a catheter into the target site.
    Device Description
    The RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP) is a two-layer construction comprised of a stainless steel mesh sandwiched between layers of polyurethane polyamide elastomer. The polyurethane polyamide elastomer contains barium sulfate for visibility and contrast under fluoroscopy. There is a hydrophilic coating on the distal portion of the device. The length of the coating is determined by the product code number.
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    K Number
    K082847
    Device Name
    PINNACLE ROII INTRODUCER SHEATH
    Manufacturer
    TERUMO MEDICAL CORP.
    Date Cleared
    2008-10-29

    (30 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    TERUMO MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pinnacle® ROII Introducer Sheath is used to facilitate placing a catheter through the skin into a vein or artery. The Mini Guide Wire is an accessory device which is used for placement of the sheath into the vein or artery. The RADIFOCUS Obturator is also an accessory device which is used by placing it into the sheath to create an occlusion and further provide support to the wall of the indwelling sheath while it remains in place within the vein or artery after removal of a catheter.
    Device Description
    The PINNACLE R/O II Introducer Sheath is comprised of an introducer sheath and a dilator. The introducer sheath has a radiopaque marker that is highly visible under fluoroscopy. The marker is a band that is located approximately 5 mm from the sheath's distal tip. The introducer sheath consists of 2 pieces of ETFE tubing -- a long segment and a short tip segment. The band is sandwiched between the two segments and fused together. The band is completely encapsulated within the tubing wall. The PINNACLE R/O II Introducer Sheath is used to facilitate placement of a catheter through the skin into a vein or artery. A Mini Guide Wire (with Inserter) may be included with the device. The Inserter does not contact blood and is used strictly for guiding the Guide Wire into a cannula or Introducer. The Mini Guide Wire is inserted through a cannula placed in the patient's blood vessel. The PINNACLE R/O II Introducer Sheath is then inserted over the Mini Guide Wire and into the blood vessel. The Mini Guide Wire is then withdrawn from the vessel. The Dilator maintains the integrity of the Sheath and dilates the blood vessel while the Introducer Sheath is being placed into the vessel. The Dilator can be removed and an appropriate catheter can then be inserted. The RADIFOCUS Obturator is an accessory device which creates an occlusion when inserted into the Sheath. The Obturator also provides support to the indwelling Sheath after the catheter is removed. The Sheath, Dilator and Obturator contain bismuth, making these devices visible under fluoroscopy.
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    K Number
    K082519
    Device Name
    FINECROSS MG CORONARY MICRO-GUIDE CATHETER
    Manufacturer
    TERUMO MEDICAL CORP.
    Date Cleared
    2008-09-26

    (24 days)

    Product Code
    KRA
    Regulation Number
    870.1210
    Why did this record match?
    Applicant Name (Manufacturer) :

    TERUMO MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The product (Finecross™ MG) is intended to be percutaneously introduced into blood vessels and support a guide wire while performing PCI (percutaneous coronary intervention). The product is also intended for injection of radiopaque contrast media for the purpose of angiography.
    Device Description
    FINECROSS MG consists of a catheter shaft, a hub and an anti-kink protector. The catheter shaft has reinforcing braided mesh, thus achieving the high shaft strength and anti-kink characteristics. The shaft has gradual hardness change from the proximal to the distal portion. This is achieved by joining outer layers of material with different hardness. By using polytetrafluoroethylene (PTFE) as the inner layer, high inner face mobility has been achieved. The outer surface of the catheter is coated with a hydrophilic polymer, therefore, it demonstrates a high lubricity upon moistening.
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    K Number
    K082736
    Device Name
    RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER
    Manufacturer
    TERUMO MEDICAL CORP.
    Date Cleared
    2008-09-24

    (6 days)

    Product Code
    DQO
    Regulation Number
    870.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    TERUMO MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Radifocus Optitorque Angiographic Catheter is intended for cardiac and vascular procedures. It is designed to deliver radiopaque media, guide wires, catheters, and therapeutic agents to selected sites in the vascular system. The different shapes are designed to selectively engage arteries from access sites such as the femoral, radial, and brachial artery.
    Device Description
    The Radifocus Optitorque Angiographic Catheter is a two-layer construction comprised of a stainless steel mesh sandwiched between layers of polyurethane polyamide elastomer. The polyurethane polyamide elastomer contains barium sulfate for visibility and contrast under fluoroscopy. The Catheter has a "soft-tip" whose purpose is to minimize trauma to the vessel wall. The soft-tip is a flexible, supple polyurethane tip that is permanently welded to the catheter shaft.
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