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510(k) Data Aggregation
K Number
K083919Device Name
AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER
Manufacturer
INVATEC INNOVATIVE TECHNOLOGIES, S.R.L.
Date Cleared
2009-03-13
(72 days)
Product Code
DQY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
INVATEC INNOVATIVE TECHNOLOGIES, S.R.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AMPHIRION DEEP 0.014" OTW PTA Balloon Dilatation Catheters, with 150 mm and 210 mm balloon lengths, are intended to dilate stenoses in the femoral, popliteal, and infra-popliteal arteries.
Device Description
The AMPHIRION DEEP 0.014" OTW PTA Balloon Dilatation Catheter is an over-thewire percutaneous transluminal angioplasty (PTA) catheter consisting of a proximal hub, coaxial dual lumen shaft, and a distal dilatation balloon. Hydrophilic coating covers the distal 240 mm of the catheter and radiopaque markers indicate the proximal and distal dilating surface of the balloon and facilitate placement across the stenosis. The AMPHIRION DEEP 0.014" OTW PTA Balloon Dilatation Catheter is compatible with 4 F introducer catheters and 0.014" diameter guidewires. The catheter is provided with useable catheter lengths of 120 cm and 150 cm.
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K Number
K052791Device Name
MODIFICATION TO: AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER
Manufacturer
INVATEC INNOVATIVE TECHNOLOGIES, S.R.L.
Date Cleared
2005-11-04
(32 days)
Product Code
DQY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
INVATEC INNOVATIVE TECHNOLOGIES, S.R.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AMPHIRION™ DEEP 0.014" OTW PTA Balloon Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Device Description
The AMPHIRION DEEP catheter is a coaxial lumen device with a semi-compliant balloon. The lumen marked "WIRE" is the central lumen of the catheter, which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire with a maximum outer diameter of 0.014". The lumen marked "BALLOON" is the balloon inflation lumen, which is used to inflate and deflate the dilatation balloon. The catheter tapers beneath the balloon segment to achieve the lowest possible deflated profile. Two radiopaque marker bands are placed under the balloon segment of the catheter shaft to provide visual reference points for balloon positioning within the vessel. The distal catheter shaft is hydrophilic coated.
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K Number
K051917Device Name
DIVER C.E. CATHETER
Manufacturer
INVATEC INNOVATIVE TECHNOLOGIES, S.R.L.
Date Cleared
2005-08-08
(24 days)
Product Code
QEZ, DXE
Regulation Number
870.5150Why did this record match?
Applicant Name (Manufacturer) :
INVATEC INNOVATIVE TECHNOLOGIES, S.R.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DIVER C.E. Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.
Device Description
The DIVER C.E. Catheter is an aspiration catheter indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system. The catheter features an aspiration lumen running through the full length of the catheter. A luer lock type hub in the proximal end allows the connection of the catheter to the extension line (High Pressure Tubing), stopcock, and syringe that are included in the catheter package. The DIVER C.E. Catheter has a central aspiration lumen and a soft, atraumatic tip. The smooth, soft, atraumatic tip has a radiopaque marker band located at 1mm from its distal end. The DIVER C.E. Catheter is available in two configurations - with and without sideholes. The catheter is a rapid exchange design, with the guide wire lumen running from the distal tip to 22.7 cm proximally in the catheter body, where the exit port is located. The catheter is compatible with guide wires with a maximum diameter of 0.014". Additionally, a 40u filter basket is also included to allow the physician to perform a post-procedure examination of the aspirated thrombi/emboli material removed during the procedure.
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K Number
K050756Device Name
SKIPPER AND SKIPPER RACE GUIDEWIRE
Manufacturer
INVATEC INNOVATIVE TECHNOLOGIES, S.R.L.
Date Cleared
2005-05-05
(43 days)
Product Code
DQX
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
INVATEC INNOVATIVE TECHNOLOGIES, S.R.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SKIPPER and SKIPPER RACE guidewires are intended for use in the peripheral and coronary vasculature.
Device Description
The SKIPPER and SKIPPER RACE are 0.014" diameter stainless steel guidewires in usable lengths of 175, 195, and 300cm. The guidewires are designed for use in interventional surgical iongallo or 170, 1999, it is introduced percutaneously into the blood vasculature and advanced to a diseased area. The SKIPPER and SKIPPER RACE guidewires contain a silicone or a hydrophilic coating.
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K Number
K050276Device Name
DIVER C.E. CATHETER
Manufacturer
INVATEC INNOVATIVE TECHNOLOGIES, S.R.L.
Date Cleared
2005-03-07
(28 days)
Product Code
QEZ, DXE
Regulation Number
870.5150Why did this record match?
Applicant Name (Manufacturer) :
INVATEC INNOVATIVE TECHNOLOGIES, S.R.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DIVER C.E. Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.
Device Description
The DIVER C.E. Catheters are aspiration catheters indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system. The catheters fresh, son emoved an lumen running through the full length of the catheter. A luer lock type hub in the proximal end allows the connection of a stopcock and a syringe for blood aspiration and clot removal (not provided). The DIVER C.E. Syringe for blood aspiration lumen and a soft, atraumatic tip. The smooth, soft, atraumatic tip has a radiopaque marker band located at 1mm from its distal end. The DIVER C.E. Catheters are available in two configurations, with and with ut sideholes. The catheters are a rapid exchange design, with the guide wire lumen running from the distal tip to 22.7 cm proximally in the catheter body, where the exit port is located. The catheters are compatible with guide wires with a maximum diameter of 0.014".
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K Number
K050073Device Name
MODIFICATION TO AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER
Manufacturer
INVATEC INNOVATIVE TECHNOLOGIES, S.R.L.
Date Cleared
2005-02-11
(30 days)
Product Code
DQY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
INVATEC INNOVATIVE TECHNOLOGIES, S.R.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AMPHIRION™ DEEP 0.014'' OTW PTA Balloon Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Device Description
The AMPHIRION DEEP catheter is a coaxial lumen device with a semi-compliant balloon. The lumen marked "WIRE" is the central lumen of the catheter, which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire with a maximum outer diameter of 0.014 inch. The lumen marked "BALLOON" is the balloon inflation lumen, which is used to inflate and deflate the dilatation balloon. The catheter tapers beneath the balloon segment to achieve the lowest possible deflated profile. Two radiopaque marker bands are placed under the balloon segment of the catheter shaft to provide visual reference points for balloon positioning within the vessel. The distal catheter shaft is hydrophilic coated.
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K Number
K042624Device Name
AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER
Manufacturer
INVATEC INNOVATIVE TECHNOLOGIES, S.R.L.
Date Cleared
2005-01-10
(105 days)
Product Code
DQY, LIT
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
INVATEC INNOVATIVE TECHNOLOGIES, S.R.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AMPHIRION™ DEEP 0.014" OTW PTA Balloon Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Device Description
The AMPHIRION DEEP catheter has a semi-compliant inflatable balloon mounted at the distal tip. It has a coaxial lumen. The central lumen of the catheter, which terminates at the distal tip, is used to pass the catheter over a guidewire with a maximum outer diameter of 0.014 inch. The other lumen is the balloon inflation lumen, which is used to inflate and deflate the dilatation balloon with a mixture of contrast medium and saline solution. The catheter tapers beneath the balloon segment to achieve the lowest possible deflated profile. Radiopaque marker bands are placed under the balloon segment of the catheter shaft to provide visual reference points for balloon positioning within the vessel. The distal catheter shaft is hydrophilic coated (balloon included). The AMPHIRION DEEP catheter is available in different balloon sizes (balloon diameters of 1.5 and 2.0 mm and balloon lengths of 20, 40, 80 and 120 mm). Nominal balloon diameter and length are printed on the hub. The maximum recommended guidewire diameter is 0.014" and the usable catheter length is 120cm.
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