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510(k) Data Aggregation
K Number
K112957Device Name
HI-TORQUE POWERTURN
Manufacturer
ABBOTT VASCULAR-CARDIAC THERAPIES
Date Cleared
2011-11-08
(35 days)
Product Code
DQX
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
ABBOTT VASCULAR-CARDIAC THERAPIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This HI-TORQUE guide wire is intended to facilitate the delivery of catheter-based interventional devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This guide wire may also be used with compatible stent devices during therapeutic procedures.
The guide wire may also be used to reach and cross a target lesion, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature.
Device Description
The HI-TORQUE POWERTURN Guide Wire Family has a diameter of 0.014" with a 190 cm extendable length and a 300 cm exchange length. The POWERTURN Guide Wire Family is available in three tip support models and is constructed from a 304V stainless steel core. Over the proximal coined section of the 190 cm model is a Wire Identifier consisting of a black PTFE shrink tube which is removable and is used to help physicians distinguish between two Abbott Vascular wires while being used simultaneously. The distal tip of the guide wire is available as a straight tip that is shapeable or as a pre-shaped "J". The straight shape allows the physician to shape the tip according to his/her preference and the pre-shaped tip provides the physician the convenience of a "J" shape without manual shaping.
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K Number
K110134Device Name
NC TREK RX CORONARY DILATATION CATHETER
Manufacturer
ABBOTT VASCULAR-CARDIAC THERAPIES
Date Cleared
2011-02-11
(24 days)
Product Code
LOX
Regulation Number
870.5100Why did this record match?
Applicant Name (Manufacturer) :
ABBOTT VASCULAR-CARDIAC THERAPIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NC TREK™ RX Coronary Dilatation Catheter is indicated for:
a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion;
b) balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction;
c) balloon dilatation of a stent after implantation (balloon models 2.0 mm - 5.0 mm only).
Device Description
The NC TREK RX Coronary Dilatation Catheter is a rapid exchange co-axial design with a balloon at the distal tip. Balloon diameters from 1.50 mm through 3.25 mm use a single layer design and balloon diameters from 3.50 mm through 5.00 mm use a co-extruded design for both predicate and new sizes. The balloon segment expands to a known diameter and length at a specific inflation pressure and has radiopaque marker(s) under the balloon to aid in positioning the balloon in a stenosis. The coaxial shaft consists of a tubular inner and outer member. The inner member permits the use of a guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The outer lumen provides for inflation and deflation of the balloon with contrast fluid. The proximal shaft consists of a hypotube with a hub on the proximal end, a tapered distal section to the guide wire notch junction, along with brachial and femoral markers.
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K Number
K103101Device Name
HI-TORQUE BALANCE MIDDLEWEIGHT ELITE
Manufacturer
ABBOTT VASCULAR-CARDIAC THERAPIES
Date Cleared
2011-02-10
(113 days)
Product Code
DQX
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
ABBOTT VASCULAR-CARDIAC THERAPIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This Guide Wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This guide wire may also be used with compatible stent devices during therapeutic procedures.
Device Description
The HI-TORQUE BALANCE MIDDLEWEIGHT™ ELITE Guide Wire is a steerable guide wire available in a maximum diameter of 0.0145" and in lengths of 190 cm and 300 cm. The distal segment of the guide wire is coated with hydrophilic coating to reduce friction for improved guide wire movement within the catheter. The distal tip is offered in a straight shapeable configuration and a pre-shaped "J" configuration. The proximal core has a maximum diameter of 0.0145". The proximal end of the guide wire is coated with hydrophobic coating, which reduces friction of the wire within a catheter. The ELITE Guide Wire is DOC® extendable in the 190 cm lengths. Over the coin DOC is a Wire Identifier to aid in distinguishing between two wires during use.
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K Number
K103110Device Name
MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM) OTW AND TREK(TM) OTW DILATATION CATHETER
Manufacturer
ABBOTT VASCULAR-CARDIAC THERAPIES
Date Cleared
2011-01-10
(94 days)
Product Code
LOX
Regulation Number
870.5100Why did this record match?
Applicant Name (Manufacturer) :
ABBOTT VASCULAR-CARDIAC THERAPIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TREK™ RX, MINI TREK™ RX, TREK™ OTW, and MINI TREK™ OTW Coronary Dilatation Catheters are indicated for:
a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion;
b) balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction;
c) balloon dilatation of a stent after implantation (balloon models 2.0 mm - 5.0 mm only).
Device Description
The TREK RX and MINI TREK RX Coronary Dilatation Catheters are a rapid exchange co-axial design with a balloon at the distal tip. The balloon segment expands to a known diameter and length at a specific inflation pressure and has radiopaque marker(s) under the balloon to aid in positioning the balloon in a stenosis. The coaxial shaft consists of a tubular inner and outer member. The inner member permits the use of a guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The outer lumen provides for inflation and deflation of the balloon with contrast fluid. The proximal shaft consists of a hypotube with a hub on the proximal end, a tapered distal section ending distal to the guide wire notch junction, along with brachial and femoral markers.
The TREK OTW and MINI TREK OTW Coronary Dilatation Catheters are an over-the-wire co-axial design with a balloon at the distal tip. The balloon segment expands to a known diameter and length at a specific inflation pressure and has radiopaque marker(s) under the balloon to aid in positioning the balloon in a stenosis. The coaxial shaft consists of a tubular inner and outer member. The inner lumen permits the use of a guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The outer lumen provides for inflation and deflation of the balloon with contrast fluid. Along the proximal portion of the shaft are brachial and femoral markers to aid in gauging the catheter's position relative to the guiding catheter tip when introducing the catheter through the guiding catheter. An adaption arm is located at the proximal end to provide access to the inflation lumen and guide wire lumen and allows connection with an inflation device.
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K Number
K103153Device Name
VOYAGER NC CORONARY DILATATION CATHETER AND NC TREK RX CORONARY DILATATION CATHETER
Manufacturer
ABBOTT VASCULAR-CARDIAC THERAPIES
Date Cleared
2010-12-30
(77 days)
Product Code
LOX
Regulation Number
870.5100Why did this record match?
Applicant Name (Manufacturer) :
ABBOTT VASCULAR-CARDIAC THERAPIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NC TREK™ RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perforusion; b) balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segement elevation myocardial infarction; c) balloon dilatation of a stent after implantation (balloon models 2.0 mm - 5.0 mm only).
Device Description
The NC TREK RX Coronary Dilatation Catheters is a rapid exchange co-axial design with a balloon at the distal tip. The balloon segment expands to a known diameter and length at a specific inflation pressure and has radiopaque marker(s) under the balloon to aid in positioning the balloon in a stenosis. The coaxial shaft consists of a tubular inner and outer member. The inner member permits the use of a guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The outer lumen provides for inflation and deflation of the balloon with contrast fluid. The proximal shaft consists of a hypotube with a hub on the proximal end, a tapered distal section ending distal to the guide wire notch junction, along with brachial and femoral markers.
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K Number
K101116Device Name
HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER LS AND MS GUIDE WIRE WITH
Manufacturer
ABBOTT VASCULAR-CARDIAC THERAPIES
Date Cleared
2010-06-23
(63 days)
Product Code
DQX
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
ABBOTT VASCULAR-CARDIAC THERAPIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HI-TORQUE PILOT Guide Wire Family is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The guide wire is also intended to facilitate the placement of compatible stent devices during therapeutic intravascular procedures.
Device Description
The HI-TORQUE PILOT™ Guide Wire with Hydrophilic Coating is a guide wire with a maximum diameter of 0.0140" and is available in a 190 cm extendable length and a 300 cm exchange length.
There are three HI-TORQUE PILOT Guide Wire designs with varying tip stiffness, the HI-TORQUE PILOT 50, HI-TORQUE PILOT 150, and HI-TORQUE PILOT 200 Guide Wires.
The distal tip of the guide wire is available either as a straight tip that is shapeable, or as a pre-shaped "J". The straight shape allows the physician to shape the tip according to his/her preference; the J shapes provide the physician the convenience of a J shape without manual shaping. Brachial and femoral markers are located on the proximal segment of the 190 cm and 300 cm guide wires to indicate when the tip of the guide wire is about to exit the guide catheter.
The proximal section of the wire is coated with polytetrafluoroethylene (PTFE). The distal, polyurethane-covered area of the wire is covered with a hydrophilic coating.
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