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510(k) Data Aggregation
K Number
K143093Device Name
0.018 Arrow GPSCath Balloon Dilatation Catheter (150 cm)
Manufacturer
HOTSPUR TECHNOLOGIES, INC.,
Date Cleared
2015-06-24
(239 days)
Product Code
LIT
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
HOTSPUR TECHNOLOGIES, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 0.018" Arrow® GPSCath™ Balloon Dilatation Catheter (150 cm) is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.
Device Description
The .018" Arrow GPSCath Balloon Dilatation Catheter (150 cm) is an 0.018" guidewire compatible PTA balloon catheter consisting of a semi-compliant angioplasty balloon fixed at the distal tip and a novel valve technology that allows iniection of fluids through the inflation lumen without removal of the quidewire. Two radiopaque markers identify the balloon working length and two radiopaque markers identify the valve to aid in angiographic placement. The proximal portion of the catheter includes an inflation female luer lock hub on the side of the handle and a quidewire female luer lock hub in the proximal end of the handle.
Balloon inflation function is achieved using an angioplasty balloon mounted to the catheter shaft like a typical PTA balloon catheter. The fluid injection function is achieved through a valve at the proximal end of the balloon that is controlled through the device handle.
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K Number
K142300Device Name
Arrow GPSCath Balloon Dialation Catheter (150 cm)
Manufacturer
HOTSPUR TECHNOLOGIES, INC.,
Date Cleared
2014-09-17
(30 days)
Product Code
LIT
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
HOTSPUR TECHNOLOGIES, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Arrow GPSCath Balloon Dilatation Catheter (150 cm) is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.
Device Description
The Arrow GPSCath Balloon Dilatation Catheter (150cm) is an 0.014" guidewire compatible PTA balloon catheter consisting of a semi-compliant angioplasty balloon fixed at the distal tip and a novel valve technology that allows injection of fluids through the inflation lumen without removal of the guidewire. Two radiopaque markers identify the balloon working length and two radiopaque markers indentify the valve to aid in angiographic placement. The proximal portion of the catheter includes an inflation female luer lock hub on the side of the handle and a guidewire female luer lock hub in the proximal end of the handle.
Balloon inflation function is achieved using an angioplasty balloon mounted to the catheter shaft like a typical PTA balloon catheter. The fluid injection function is achieved through a valve at the proximal end of the balloon that is controlled through the device handle.
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K Number
K140351Device Name
ARROW GPSCATH BALLOON DILATATION CATHETER
Manufacturer
HOTSPUR TECHNOLOGIES,INC SUBSIDIARY OF TELEFLEX ME
Date Cleared
2014-07-02
(141 days)
Product Code
LIT
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
HOTSPUR TECHNOLOGIES,INC SUBSIDIARY OF TELEFLEX ME
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Arrow GPSCath™ Balloon Dilatation Catheter (150 cm) is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.
Device Description
The Arrow GPSCath Balloon Dilatation Catheter (150cm) is an 0.014" quidewire compatible PTA balloon catheter consisting of a semi-compliant angioplasty balloon fixed at the distal tip and a novel valve technology that allows injection of fluids through the inflation lumen without removal of the guidewire. Two radiopaque markers identify the balloon working length and two radiopaque markers indentify the valve to aid in angiographic placement. The proximal portion of the catheter includes an inflation female luer lock hub on the side of the handle and a guidewire female luer lock hub in the proximal end of the handle.
Balloon inflation function is achieved using an angioplasty balloon mounted to the catheter shaft like a typical PTA balloon catheter. The fluid injection function is achieved through a valve at the proximal end of the balloon that is controlled through the device handle.
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K Number
K130397Device Name
ARROW GPSCATH BALLOON DILATATION CATHETER
Manufacturer
HOTSPUR TECHNOLOGIES
Date Cleared
2013-06-20
(121 days)
Product Code
LIT
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
HOTSPUR TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Arrow GPSCath Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.
Device Description
The proposed Arrow GPSCath Balloon Dilatation Catheter is designed for dilation of peripheral vessels in the arterial system and native or synthetic arteriovenous dialysis fistulae in the treatment of obstructive lesions. The Arrow GPSCath Balloon Dilatation Catheter is a 0.035" guide-wire compatible, PTA balloon catheter with a proprietary proximal valve system which allows injection of fluids. By providing an angioplasty balloon with fluid delivery capability, the user is able to treat obstructive lesions within the arterial system and arteriovenous dialysis fistulae without having to lose guidewire position.
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K Number
K113769Device Name
GPSCATH BALLON DILATATION CATHETER
Manufacturer
HOTSPUR TECHNOLOGIES
Date Cleared
2012-01-20
(29 days)
Product Code
LIT
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
HOTSPUR TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The GPSCath Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.
Device Description
The GPSCath Balloon Dilatation Catheter is designed for dilation of peripheral vessels in the arterial svstem and native or synthetic arteriovenous dialysis fistulae in the treatment of obstructive lesions. The GPSCath Balloon Dilatation Catheter is a 0.035" guide-wire compatible, PTA balloon catheter with a proprietary proximal valve system which allows injection of fluids. By providing an angioplasty balloon with fluid delivery capability, the user is able to treat obstructive lesions within the arterial system and arteriovenous dialysis fistulae without having to lose guidewire position.
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K Number
K101047Device Name
PTA-DUO PTA BALLOON CATHETER
Manufacturer
HOTSPUR TECHNOLOGIES
Date Cleared
2010-07-13
(90 days)
Product Code
LIT
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
HOTSPUR TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PTA-Duo PTA Balloon Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.
Device Description
The PTA-Duo PTA Balloon Catheter is designed for dilation of peripheral vessels in the arterial system and native or synthetic arteriovenous dialysis fistulae in the treatment of obstructive lesions. The PTA-Duo PTA Balloon Catheter is a 0.035" guide-wire compatible, non-compliant, high pressure balloon catheter with a proprietary valve system which allows distal injection of contrast media without the need to remove the guidewire. By providing an angioplasty balloon with distal contrast injection capability. the user is able to treat obstructive lesions within the arteriovenous dialysis fistulae without having to lose guidewire position to visualize the result.
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K Number
K100840Device Name
EMBO PLUS EMBOLECTOMY CATHETER
Manufacturer
HOTSPUR TECHNOLOGIES
Date Cleared
2010-07-12
(110 days)
Product Code
DXE
Regulation Number
870.5150Why did this record match?
Applicant Name (Manufacturer) :
HOTSPUR TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EMBO-Plus Embolectomy Catheter is indicated for use within vessels in the arterial system and synthetic arteriovenous dialysis fistulae for the removal of fresh, soft emboli and thrombi.
Device Description
The proposed EMBO-Plus Embolectomy Catheter is designed for the removal of fresh, soft emboli and thrombi from within vessels in the arterial system and synthetic arteriovenous dialysis fistulae. The EMBO-Plus Embolectomy Catheter is an .035" guide-wire compatible, compliant embolectomy balloon system with a proprietary valve system which allows injection of physician specified agents without the need to remove the guidewire. By providing two functions within the catheter the operator is able to remove fresh, soft emboli and thrombi from within the arterial system and synthetic arteriovenous dialysis fistulae without having to lose guidewire position.
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K Number
K100842Device Name
PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CM
Manufacturer
HOTSPUR TECHNOLOGIES
Date Cleared
2010-07-12
(109 days)
Product Code
DXE, LIT
Regulation Number
870.5150Why did this record match?
Applicant Name (Manufacturer) :
HOTSPUR TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PTA-Plus PTA Balloon Catheter is indicated for use within synthetic arteriovenous dialysis fistulae to remove embolic material (thrombus/debris) and dilate stenosis for treatment of obstructive lesions.
Device Description
The proposed PTA-Plus PTA Balloon Catheter is designed for de-clotting and treating stenosis in synthetic dialysis grafts. It is an .035" guide-wire compatible, PTA balloon catheter with a proprietary valve system which allows injection of contrast and an embolectomy coil for mechanical removal of thrombus.
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