Search Filters

Search Results

Found 10 results

510(k) Data Aggregation

    K Number
    K172264
    Device Name
    OTW Takeru PTCA Balloon Dilatation Catheter
    Manufacturer
    Kaneka Corporation
    Date Cleared
    2018-03-19

    (235 days)

    Product Code
    LOX
    Regulation Number
    870.5100
    Why did this record match?
    Applicant Name (Manufacturer) :

    Kaneka Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OTW Takeru PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion in the coronary artery or bypass graft stenosis for the purpose of myocardial perfusion. This product (balloon models 2.0 – 5.0 mm) is also indicated for the post-delivery expansion of balloon expandable stents.
    Device Description
    OTW Takeru PTCA Balloon Dilatation Catheter (OTW Takeru) is an over-the-wire balloon dilation catheter, which consists of a distal tube, mid tube, proximal tube, balloon, guidewire transition tube, radiopaque marker(s), manifold, and strain relief. A balloon is attached to the distal end of the catheter, and it can be inflated and deflated using the inflation device connected to the manifold at the proximal end. OTW Takeru has a lumen at the distal end of the catheter through which a guidewire can be inserted. This lumen extends from the distal end of the catheter to the guidewire port on the manifold for the guidewire. The maximum compatible diameter of a guidewire used together with OTW Takeru in a PTCA procedure is 0.014 inches. Additionally, guiding catheters with a diameter of 5 or 6 Fr have been deemed to be compatible with OTW Takeru. The nominal inflated balloon diameters range from 1.5 mm to 5.0 mm with balloon working lengths of 6 mm to 30 mm. The catheter working length is 1450 mm.
    Ask a Question
    K Number
    K170941
    Device Name
    RX NC Takeru PTCA Balloon Dilatation Catheter
    Manufacturer
    Kaneka Corporation
    Date Cleared
    2017-07-07

    (99 days)

    Product Code
    LOX
    Regulation Number
    870.5100
    Why did this record match?
    Applicant Name (Manufacturer) :

    Kaneka Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RX NC Takeru PTCA Balloon Dilatation Catheter is indication of the stenotic portion in the coronary artery or bypass graft stenosis for the purpose of myocardial perfusion. This product is also indicated for the post-delivery expansion of balloon expandable stents.
    Device Description
    RX NC Takeru PTCA Balloon Dilatation Catheter (RX NC Takeru) is a rapid exchange type of balloon dilation catheter, which consists of a distal tube, guidewire transition tube, balloon, radiopaque markers, mid tube, proximal tube, core wire, hub, and strain relief. A balloon is attached to the distal end of the catheter, and it can be inflated and deflated using the inflation device connected to the hub at the proximal end. RX NC Takeru has a guidewire lumen at the distal end of the catheter through which a guidewire can be inserted, and also an opening along the guidewire transition tube to the guidewire port for the exit of a guidewire. The maximum compatible diameter of a guidewire used together with RX NC Takeru in a PTCA procedure is 0.014 inches. Additionally, guiding catheters with a diameter of 5 or 6 Fr have been deemed to be compatible with RX NC Takeru. The nominal inflated balloon diameters range from 2.0 mm to 5.0 mm with balloon working lengths of 6 mm to 30 mm. The catheter working length is 1450 mm.
    Ask a Question
    K Number
    K163372
    Device Name
    RX Takeru Balloon Dilatation Catheter
    Manufacturer
    KANEKA CORPORATION
    Date Cleared
    2017-04-07

    (127 days)

    Product Code
    LOX
    Regulation Number
    870.5100
    Why did this record match?
    Applicant Name (Manufacturer) :

    KANEKA CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RX Takeru PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion in the coronary artery or bypass graft stenosis for the purpose of myocardial perfusion. This product (balloon models 2.0-5.0 mm) is also indicated for the post-delivery expansion of balloon expandable stents.
    Device Description
    Rx Takeru PTCA Balloon Dilatation Catheter (Rx Takeru) is a rapid exchange type of balloon dilation catheter, which consists of a distal tube, guidewire transition tube, balloon, radiopaque marker(s), mid tube, proximal tube, core wire, hub, and strain relief. A balloon is attached to the distal end of the catheter, and it can be inflated and deflated using the inflation device connected to the hub at the proximal end. Rx Takeru has a guidewire lumen at the distal end of the catheter through which a guidewire can be inserted, and also an opening along the guidewire transition tube to the guidewire port for the exit of a guidewire. The maximum compatible diameter of a guidewire used together with Rx Takeru in a PTCA procedure is 0.014 inches. Additionally, guiding catheters with a diameter of 5 or 6 Fr have been deemed to be compatible with Rx Takeru. The nominal inflated balloon diameters range from 1.5 mm to 5.0 mm with balloon working lengths of 6 mm to 30 mm. The catheter working length is 1450 mm.
    Ask a Question
    K Number
    K163479
    Device Name
    R2P Metacross RX
    Manufacturer
    KANEKA CORPORATION
    Date Cleared
    2017-01-11

    (30 days)

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

    KANEKA CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The R2P Metacross RX PTA balloon dilatation catheter is intended to dilate stenoral, ilio-femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.
    Device Description
    R2P Metacross RX PTA Balloon Dilatation Catheter (R2P Metacross RX) is a rapid exchange balloon dilation catheter, which consists of a distal tube, proximal tube, balloon, guidewire transition tube, radiopaque markers, hub, and strain relief. A balloon is attached to the distal end of the catheter, and it can be inflated and deflated using the inflation device connected to the hub at the proximal end. R2P Metacross RX has a lumen (guidewire transition tube) at the distal end of the catheter through which a guidewire can be inserted, and also an opening along the balloon and distal tube to the guidewire port for the exit of a guidewire. The maximum compatible diameter of a guidewire used together with R2P Metacross RX in a PTA procedure is 0.035 inches. Additionally, sheath introducers with a minimum diameter of 6 Fr have been deemed to be compatible with R2P Metacross RX. The nominal inflated balloon diameters range from 3.0 mm to 8.0 mm with balloon working lengths of 20 mm to 200 mm. The catheter working length is 2000 mm. The R2P Metacross RX is provided with the following accessory device: - Flushing Needle: provided per one catheter device for the purpose of flushing and filling of the guidewire lumen with heparinized saline before use.
    Ask a Question
    K Number
    K160004
    Device Name
    Crosstella OTW
    Manufacturer
    KANEKA CORPORATION
    Date Cleared
    2016-04-29

    (116 days)

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

    KANEKA CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Crosstella OTW PTA Balloon Dilatation Catheter is intended to dilate stenoral, ilio-femoral, popliteal, infrapoplited and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.
    Device Description
    Crosstella OTW PTA Balloon Dilatation Catheter (Crosstella OTW) is an over-the-wire type of balloon dilation catheter, which consists of an outer tube, inner tube, balloon, radiopaque markers, manifold, outer reinforcement tube and strain relief. A balloon is attached to the distal end of the catheter, and it can be inflated and deflated using the inflation device connected to the manifold at the proximal end. Crosstella OTW has a guidewire lumen at the distal end of the catheter through which a guidewire can be inserted, and also an opening along the inner tube to the guidewire port of the manifold for the introduction of a guidewire. The maximum compatible diameter of a guidewire used together with Crosstella OTW in a PTA procedure is 0.018 inches. Additionally, the compatible size of a sheath introducer is 4 The nominal inflated balloon diameters range from 2.0 mm to 6.0 mm with balloon or 5 Fr. working lengths of 20 mm to 200 mm. Two different catheter working lengths will be provided: 900 and 1500 mm.
    Ask a Question
    K Number
    K160013
    Device Name
    Crosperio OTW
    Manufacturer
    KANEKA CORPORATION
    Date Cleared
    2016-04-29

    (116 days)

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

    KANEKA CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Crosperio OTW PTA Balloon Dilatation Catheter is intended to dilate stenosis in the iliac, femoral, popliteal, infrapoplited and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.
    Device Description
    Crosperio OTW PTA Balloon Dilatation Catheter (Crosperio OTW) is an over-the-wire type of balloon dilatation catheter, which consists of an outer tube, inner tube, balloon, radiopaque markers, manifold, outer reinforcement tube and strain relief. A balloon is attached to the distal end of the catheter, and it can be inflated and deflated using the inflation device connected to the manifold at the proximal end. Crosperio OTW has a guidewire lumen at the distal end of the catheter through which a guidewire can be inserted, and also an opening along the inner tube to the guidewire port of the manifold for the introduction of a guidewire. The maximum compatible diameter of a guidewire used together with Crosperio OTW in a PTA procedure is 0.014 inches. Additionally, the compatible size of a sheath introducer is 4 Fr. The nominal inflated balloon diameters range from 1.5 mm to 4.0 mm with balloon working lengths of 20 mm to 200 mm. Three different catheter working lengths will be provided: 650, 900 and 1500 mm.
    Ask a Question
    K Number
    K152873
    Device Name
    Crosstella RX Balloon Dilatation Catheter
    Manufacturer
    KANEKA CORPORATION
    Date Cleared
    2016-01-22

    (114 days)

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

    KANEKA CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Crosstella RX PTA Balloon Dilatation Catheter is intended to dilate stenosis in the iliac, femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.
    Device Description
    Crosstella RX PTA Balloon Dilatation Catheter (Crosstella RX) is a rapid exchange balloon dilation catheter, which consists of a distal tube, proximal tube, balloon, guidewire transition tube, radiopaque markers, hub, and strain relief. A balloon is attached to the distal end of the catheter and it can be inflated and deflated using the inflation device connected to the hub at the proximal end. Crosstella RX has a lumen (guidewire transition tube) at the distal end of the catheter through which a guidewire can be inserted, and also an opening along the balloon and distal tube to the guidewire port for the introduction of a guidewire. The maximum compatible diameter of a guidewire used together with Crosstella RX in a PTA procedure is 0.018 inches; hence, sheath introducers with a minimum diameter of 4 or 5 Fr have been deemed to be compatible with Crosstella RX. The nominal inflated balloon diameters range from 2.0 mm to 6.0 mm with balloon working lengths of 20 mm to 200 mm. Three different catheter working lengths will be provided: 900, 1500 and 2000 mm. The Crosstella RX is provided with the following accessory device: - . Flushing Needle: provided per one catheter device for the purpose of flushing and filling of the guidewire lumen with heparinized saline before use.
    Ask a Question
    K Number
    K152887
    Device Name
    Crosperio RX PTA Balloon Dilatation Catheter
    Manufacturer
    Kaneka Corporation
    Date Cleared
    2016-01-22

    (114 days)

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

    Kaneka Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Crosperio RX PTA Balloon Dilatation Catheter is intended to dilate stenosis in the iliac, femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.
    Device Description
    Crosperio RX PTA Balloon Dilatation Catheter (Crosperio RX) is a rapid exchange balloon dilation catheter, which consists of a distal tube, proximal tube, balloon, guidewire transition tube, radiopaque markers, hub, and strain relief. A balloon is attached to the distal end of the catheter and it can be inflated and deflated using the inflation device connected to the hub at the proximal end. Crosperio RX has a lumen (guidewire transition tube) at the distal end of the catheter through which a guidewire can be inserted, and also an opening along the balloon and distal tube to the guidewire port for the introduction of a guidewire. The maximum compatible diameter of a guidewire used together with Crosperio RX in a PTA procedure is 0.014 inches; hence, sheath introducers with a minimum diameter of 4 Fr have been deemed to be compatible with Crosperio RX. The nominal inflated balloon diameters range from 1.5 mm to 4.0 mm with balloon working lengths of 20 mm to 200 mm. Two different catheter working lengths will be provided: 900 and 1500 mm. The Crosperio RX is provided with the following accessory device: - Flushing Needle: provided per one catheter device for the purpose of flushing and filling . of the guidewire lumen with heparinized saline before use.
    Ask a Question
    K Number
    K152080
    Device Name
    Metacross OTW PTA Balloon Dilatation Catheter
    Manufacturer
    Kaneka Corporation
    Date Cleared
    2015-09-24

    (59 days)

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

    Kaneka Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Metacross OTW PTA Balloon Dilatation Catheter is intended to dilate stenoral, ilio-femoral, popliteal, infrapopliteal and renal arteries, and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.
    Device Description
    Metacross OTW PTA Balloon Dilatation Catheter (Metacross OTW) is an over the wire type of balloon dilation catheter, which consists of a distal tube, center tube, proximal tube, balloon, guidewire transition tube, radiopaque markers, manifold, and strain relief. A balloon is attached to the distal end of the catheter, and it can be inflated and deflated using the inflation device connected to the manifold at the proximal end. Metacross OTW has a guidewire lumen at the distal end of the catheter through which a guidewire can be inserted, and also an opening along the guidewire transition tube, center tube and proximal tube to the guidewire port of the manifold for the introduction of a guidewire. The maximum compatible diameter of a guidewire used together with Metacross OTW in a PTA procedure is 0.035 inches; hence, sheathless guiding catheters and sheaths with a diameter of 5, 6 or 7 Fr have been deemed to be compatible with Metacross OTW. The nominal inflated balloon diameters range from 3.0 mm with balloon working lengths of 20 mm to 200 mm. Three different catheter working lengths will be provided: 650, 900 and 1350 mm.
    Ask a Question
    K Number
    K150865
    Device Name
    Metacross RX PTA Balloon Dilitation Catheter
    Manufacturer
    Kaneka Corporation
    Date Cleared
    2015-08-03

    (124 days)

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

    Kaneka Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Metacross RX PTA Balloon Dilatation Catheter is intended to dilate stenosis in the iliac, femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.
    Device Description
    Metacross RX PTA Balloon Dilatation Catheter (Metacross RX) is a rapid exchange balloon dilation catheter, which consists of a distal tube, proximal tube, balloon, guidewire transition tube, radiopaque markers, hub, and strain relief. A balloon is attached to the distal end of the catheter, and it can be inflated and deflated using the inflation device connected to the hub at the proximal end. Metacross RX has a lumen (guidewire transition tube) at the distal end of the catheter through which a guidewire can be inserted, and also an opening along the balloon and distal tube to the guidewire port for the introduction of a guidewire. The maximum compatible diameter of a guidewire used together with Metacross RX in PTA procedure is 0.035 inches; hence, sheathless guiding catheters and sheaths with a diameter of 6 or 7 Fr have been deemed to be compatible with Metacross RX. The nominal inflated balloon diameters range from 3.0 mm to 12.0 mm with balloon working lengths of 20 mm to 200 mm. Three different catheter working lengths will be provided: 900, 1350 and 2000 mm. The Metacross RX is provided with the following accessory device: . Flushing Needle: provided per one catheter device for the purpose of flushing and filling of the guidewire lumen with heparinized saline before use.
    Ask a Question

    Page 1 of 1