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510(k) Data Aggregation
K Number
K170403Device Name
CenterCross Ultra LV Catheter
Manufacturer
Roxwood Medical, Inc.
Date Cleared
2017-03-07
(26 days)
Product Code
DQY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
Roxwood Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CenterCross ULTRA LV Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices.
Device Description
The CenterCross Ultra LV Catheter is a sterile, single lumen over-the-wire support catheter to be used in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature to facilitate exchange of guidewires and other interventional devices. The CenterCross Ultra LV Catheter consists of an outer shaft and a removable handle/inner shaft assembly that allows for manual device manipulation. A key element of the device is an expandable and retractable nitinol structure, which, when deployed by the physician, expands to the artery wall to aid interventionalists in establishing greater support near the treatment site.
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K Number
K152957Device Name
MultiCross Catheter
Manufacturer
ROXWOOD MEDICAL, INC.
Date Cleared
2016-03-04
(149 days)
Product Code
DQY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
ROXWOOD MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MultiCross Support Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary or peripheral vasculature and for guidewire exchange.
Device Description
The MultiCross Catheter consists of an inner shaft, outer shaft, and a proximal handle that allows for manual device manipulation and a means for flushing the catheter lumen. A key element of the device is an expandable and retractable nitinol scaffold, which, when deployed by the physician, expands to the artery wall to aid the user in establishing greater support near the treatment site.
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K Number
K152456Device Name
CenterCross Ultra Catheter
Manufacturer
ROXWOOD MEDICAL, INC.
Date Cleared
2016-01-26
(151 days)
Product Code
DQY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
ROXWOOD MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CenterCross Ultra Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices.
Device Description
The CenterCross Ultra Catheter is a sterile, single-use, single lumen over-the-wire support catheter to be used in conjunction with steerable guidewires to access discrete regions of the coronary and peripheral vasculature to facilitate exchange of guidewires and other interventional devices.
The CenterCross Ultra Catheter consists of an outer shaft and a removable handle/inner shaft assembly that allows for manual device manipulation. A kev element of the device is an expandable and retractable nitinol structure, which, when deployed by the physician, expands to the artery wall to aid interventionalists in establishing greater support near the treatment site.
Subsequent to conventional guidewire placement, atherectomy devices, PTCA catheters, and/or stents may be used to provide therapeutic benefit. The CenterCross Ultra Catheter in and of itself does not provide therapeutic benefit beyond simple facilitation of guidewire and device support. The CenterCross Ultra Catheter is similar in its design and achieves its intended use by means of the same mechanisms as the predicate device.
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K Number
K151082Device Name
MicroCross Catheter
Manufacturer
ROXWOOD MEDICAL, INC.
Date Cleared
2015-06-07
(46 days)
Product Code
DQY, DOY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
ROXWOOD MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MicroCross Catheter is intended for use as a conduit for the exchange/support of guidewires in the peripheral and coronary vasculatures. The MicroCross Catheter is also intended to infuse and contrast agents.
Device Description
The MicroCross Catheter is a sterile, single lumen over-the-wire catheter to be used for the exchange and support of guidewires in the peripheral and coronary vasculatures. The MicroCross Catheter also infuses and delivers saline and contrast agents.
The MicroCross Catheter consists of a catheter shaft and a proximal hub that provides strain relief. The MicroCross Catheter is offered with a working length of 155cm and is compatible with 0.018" diameter guidewires, 5F guide catheters, and 4F introducer sheaths.
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K Number
K143744Device Name
MicroCross Catheter
Manufacturer
ROXWOOD MEDICAL, INC.
Date Cleared
2015-04-14
(104 days)
Product Code
DQY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
ROXWOOD MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MicroCross Catheter is intended for use as a conduit for the exchange/support of guidewires in the peripheral and coronary vasculatures. The MicroCross Catheter is also intended to infuse and contrast agents.
The MicroCross Catheter is intended for use as a conduit for the exchange/support of guidewires in the peripheral and coronary vasculatures. The MicroCross Catheter is also intended to infuse and deliver saline and contrast agents.
Device Description
The MicroCross Catheter is a sterile, single lumen over-the-wire catheter to be used for the exchange and support of guidewires in the peripheral and coronary vasculatures. The MicroCross Catheter also infuses and delivers saline and contrast agents.
The MicroCross Catheter consists of a catheter shaft and a proximal hub that provides strain relief. The MicroCross Catheter is offered in working lengths of 150cm and 155cm and is compatible with 0.014" diameter guidewires, 5F guide catheters, and 4F introducer sheaths.
Subsequent to conventional guidewire placement, interventional tools such as angioplasty, stent, and atherectomy devices, may be used to provide therapeutic benefit. The MicroCross Catheter in and of itself does not provide therapeutic benefit beyond simple facilitation of guidewire support. The MicroCross Catheter is similar in its design and it achieves its intended use by means of the same mechanisms as the predicate device.
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K Number
K140910Device Name
CENTERCROSS CATHETER
Manufacturer
ROXWOOD MEDICAL, INC.
Date Cleared
2014-11-19
(224 days)
Product Code
DQY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
ROXWOOD MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CenterCross Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices.
Device Description
The CenterCross Catheter is a sterile, single-use, single lumen over-the-wire support catheter to be used in conjunction with steerable guidewires to access discrete regions of the coronary and peripheral vasculature to facilitate exchange of guidewires and other interventional devices.
The CenterCross Catheter consists of an inner shaft, outer sheath, and a proximal handle that allows for manual device manipulation and a means for flushing the catheter lumen. A key element of the device is a temporarily expandable and retractable nitinol structure, which when deployed by the physician expands to the width of the artery to aid interventionalists in establishing greater support near the treatment site.
Subsequent to conventional guidewire placement, atherectomy devices, PTCA catheters, and/or stents may be used to provide therapeutic benefit. The CenterCross Catheter in and of itself does not provide therapeutic benefit beyond simple facilitation of guidewire support. The CenterCross Catheter is similar in its design and it achieves its intended use by means of the same mechanisms as the predicate devices.
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K Number
K121763Device Name
MULTICROSS SUPPORT CATHETER
Manufacturer
ROXWOOD MEDICAL, INC.
Date Cleared
2012-11-27
(165 days)
Product Code
DQY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
ROXWOOD MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MultiCross Support Catheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the coronary and peripheral vasculature and for guidewire exchange.
Device Description
The MultiCross Support Catheter is a sterile, single-use, triple lumen, over-the-wire, disposable percutaneous support catheter designed for use in conjunction with a steerable guidewire to access discrete regions of the coronary and peripheral vasculature for guidewire exchange. The MultiCross Support Catheter consists of an inner shaft, outer sheath, and a proximal handle that allows for manual device manipulation and a means for flushing the catheter lumen. A key element of the device is a temporarily deployable and retractable distal Nitinol scaffold, which is visible through fluoroscopy when deployed by the user, and expands to the width of the artery to provide an anchoring to aid the user in establishing greater support near the treatment site. Subsequent to conventional guidewire placement, therapeutic devices such as atherectomy devices, PTCA catheters, and/or stents may be used to provide therapeutic benefit. The MultiCross Support Catheter by itself does not provide therapeutic benefit beyond simple facilitation of guidewire support.
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