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510(k) Data Aggregation
K Number
K172264Device Name
OTW Takeru PTCA Balloon Dilatation Catheter
Manufacturer
Kaneka Corporation
Date Cleared
2018-03-19
(235 days)
Product Code
LOX
Regulation Number
870.5100Why 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.
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K Number
K170941Device Name
RX NC Takeru PTCA Balloon Dilatation Catheter
Manufacturer
Kaneka Corporation
Date Cleared
2017-07-07
(99 days)
Product Code
LOX
Regulation Number
870.5100Why 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.
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K Number
K163372Device Name
RX Takeru Balloon Dilatation Catheter
Manufacturer
KANEKA CORPORATION
Date Cleared
2017-04-07
(127 days)
Product Code
LOX
Regulation Number
870.5100Why 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.
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K Number
K163479Device Name
R2P Metacross RX
Manufacturer
KANEKA CORPORATION
Date Cleared
2017-01-11
(30 days)
Product Code
LIT
Regulation Number
870.1250Why 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.
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K Number
K160004Device Name
Crosstella OTW
Manufacturer
KANEKA CORPORATION
Date Cleared
2016-04-29
(116 days)
Product Code
LIT
Regulation Number
870.1250Why 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.
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K Number
K160013Device Name
Crosperio OTW
Manufacturer
KANEKA CORPORATION
Date Cleared
2016-04-29
(116 days)
Product Code
LIT
Regulation Number
870.1250Why 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.
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K Number
K152873Device Name
Crosstella RX Balloon Dilatation Catheter
Manufacturer
KANEKA CORPORATION
Date Cleared
2016-01-22
(114 days)
Product Code
LIT
Regulation Number
870.1250Why 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.
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K Number
K152887Device Name
Crosperio RX PTA Balloon Dilatation Catheter
Manufacturer
Kaneka Corporation
Date Cleared
2016-01-22
(114 days)
Product Code
LIT
Regulation Number
870.1250Why 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.
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K Number
K152080Device Name
Metacross OTW PTA Balloon Dilatation Catheter
Manufacturer
Kaneka Corporation
Date Cleared
2015-09-24
(59 days)
Product Code
LIT
Regulation Number
870.1250Why 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.
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K Number
K150865Device Name
Metacross RX PTA Balloon Dilitation Catheter
Manufacturer
Kaneka Corporation
Date Cleared
2015-08-03
(124 days)
Product Code
DQY, DOY
Regulation Number
870.1250Why 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.
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