Search Filters

Search Results

Found 9 results

510(k) Data Aggregation

    K Number
    K012534
    Device Name
    HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
    Manufacturer
    ADVANCED CARDIOVASCULAR SYSTEMS, INC.
    Date Cleared
    2002-01-24

    (171 days)

    Product Code
    DQX
    Regulation Number
    870.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED CARDIOVASCULAR SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA), percutaneous transluminal angioplasty (PTA) and compatible stent devices during therapeutic intravascular procedures.
    Device Description
    The HI-TORQUE MIDDLE SUPPORT™ .012" Guide Wire with HYDROCOAT™ Hydrophilic Coating is a guide wire with a nominal diameter of 0.012". Like the ACS HI-TORQUE TRA VERSE® Guide Wire, the HI-TORQUE MIDDLE SUPPORT™ .012" Guide Wire is constructed from a stainless steel core. The distal segment of the guide wire includes a series of tapers and a flat, which reduce the diameter and stiffness of the distal core, thus yielding the desired flexibility and performance. The distal tip coil has a radiopaque length of 3 cm. The distal end of the guide wire is available either as a straight tip that is shapeable, or as a pre-shaped "J". The HI-TORQUE MIDDLE SUPPORT™ .012" Guide Wire with HYDROCOAT™ Hydrophilic Coating is available in lengths of 190 cm and 300 cm exchange length. The 300 cm exchange length enables the physician ample working length of the guide wire to facilitate catheter exchanges. The proximal section of the wire is coated with polytetrafluoroethylene (PTFE). The distal, coiled segment of the wire is coated with HYDROCOAT™ Hydrophilic Coating.
    Ask a Question
    K Number
    K000550
    Device Name
    OTW MEGALINK SDS BILIARY STENT SYSTEM
    Manufacturer
    ADVANCED CARDIOVASCULAR SYSTEMS, INC.
    Date Cleared
    2000-03-17

    (28 days)

    Product Code
    FGE
    Regulation Number
    876.5010
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED CARDIOVASCULAR SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K994229
    Device Name
    VERIPATH PERIPHERAL GUIDING CATHETER
    Manufacturer
    ADVANCED CARDIOVASCULAR SYSTEMS, INC.
    Date Cleared
    2000-02-25

    (71 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED CARDIOVASCULAR SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The peripheral guiding catheter is intended to provide a pathway through which therapeutic and diagnostic devices are introduced into the peripheral vasculature. The inner catheter is intended to provide support during the introduction and withdrawal of a guiding catheter.
    Device Description
    The VERIPATH™ Peripheral Guiding Catheter is recommended for use during vascular procedures in conjunction with interventional and/or diagnostic devices such as balloon dilatation catheters, atherectomy devices, stent delivery systems, intravascular ultrasound devices, etc. The guiding catheter is a single lumen catheter that allows contrast medium iniections and facilitates the intravascular passage of diagnostic and therapeutic devices into the vascular system. The guiding catheter has a standard working length of 50 cm and a standard overall length of 56 cm, but can be produced in overall lengths from 40 to 80 cm, depending upon physician preference and patient size. The guiding catheter is available in three diameters/French sizes (F), as follows: 6F (0.068" ID, 0.82" OD), 7F (0.078" ID, 0.93" OD), 8F (0.088" ID, 0.105" OD). The guiding catheter is available in varying tip shapes designed for peripheral use. Each shape is specific for patient anatomy and physician preference, and therefore a wide range of shapes is available. Also included in the VERIPATH™ device package is an inner catheter. The inner catheter is a single lumen catheter with a luer at the proximal end and is recommended for use with the guiding catheter to aid in the introduction and withdrawal of the guiding catheter. The inner catheter has a standard working length of 65 cm and a standard overall length of 67 cm, but can be produced in lengths from 55 to 95 cm depending upon physician preference and patient size. The inner catheter is straight and available in three diameters/French sizes (F), as follows: 6F (0.062" OD), 7F (0.072" OD), and 8F (0.082" OD) and may be sold either with or without a taper at the tip.
    Ask a Question
    K Number
    K992169
    Device Name
    ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE
    Manufacturer
    ADVANCED CARDIOVASCULAR SYSTEMS, INC.
    Date Cleared
    1999-10-28

    (122 days)

    Product Code
    DQX
    Regulation Number
    870.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED CARDIOVASCULAR SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To facilitate the placement of balloon dilatation catheters during percutancous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).
    Device Description
    The ACS HI-TORQUE CROSS-IT™ 400XT Guide Wire with HYDROCOAT™ Hydrophilic Coating is a steerable guide wires with a nominal diameter of 014" and available in: 175 cm and 190 cm extendable lengths and a 300 cm exchange length. The proximal end of the 190 cm models are tapcred to fit into the hypotube portion of the ACS DOC® Guide Wire Extension. The wire is constructed from a stainless steel core wire. The distal end of the guide wire has a radiopaque tip that are available either as a straight or as a preshaped J. A hydrophilic coating is applied to the distal portion of the guide wire and the proximal section is coated with polytetrafluoroethylene.
    Ask a Question
    K Number
    K990867
    Device Name
    RX HERCULINK 14 BILIARY STENT SYSTEM, MODEL 1005126-18,1005128-18,1005130-18,1005132-18,1005134-18,1005136-18,1005138-18
    Manufacturer
    ADVANCED CARDIOVASCULAR SYSTEMS, INC.
    Date Cleared
    1999-09-02

    (170 days)

    Product Code
    FGE
    Regulation Number
    876.5010
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED CARDIOVASCULAR SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RX HERCULINK™ 14 Biliary Stent System is indicated for palliation of malignant strictures in the biliary tree.
    Device Description
    RX HERCULINK™ 14 Biliary Stent System is a balloon-expandable stent pre-mounted onto a rapid exchange (RX) delivery catheter designed to be placed perculaneously into the common bile duct and intended to treat malignant strictures in the biliary tree. The stent is fabricated from a single piece of 316L medical grade stainless steel tubing. The Stent is pre-mounted onto an RX delivery catheter with an integrated shaft system and an of a single have a look balloon bonded at the distal end. The shaft has a combination of a single lumen design at the proximal end and a coaxial lumen at the distal end. The proximal lumen provides for inflation of the balloon with contrast medium. The distal lumen permits use of a guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The balloon, which has 2 radiopaque markers to aid in positioning the balloon in the stenosis, is designed to provide an expandable segment of known diameter and length at specific pressures. The proximal end of the catheter has a single arm adapter that provides access to the The proximal end of the catherer has a ongro annelly for connection with an inflation device. The RX HERCULINK™ Biliary Stent System consists of an 18 mm length stent pre-The KA TILICOEINN - Dinary Catheter with balloon diameters of 4.0, 4.5, 5.0, mounted only a 75 cm length don'tory actively Stent System is intended to be delivered and deployed in the biliary tree.
    Ask a Question
    K Number
    K963702
    Device Name
    ACS HI-TORQUE IRON MAN GUIDE WIRE
    Manufacturer
    ADVANCED CARDIOVASCULAR SYSTEMS, INC.
    Date Cleared
    1997-01-22

    (128 days)

    Product Code
    DQX
    Regulation Number
    870.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED CARDIOVASCULAR SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HI-TORQUE IRON MAN™ Guide Wire is a steerable guide wire intended to facilitate placement of balloon dilatation catheters during Percutaneous Transluminal Coronary Angioplasty (PTCA) and Percutaneous Transluminal Angioplasty (PTA). The wire is also intended to facilitate the placement of equipment, such as atherectomy and compatible stent devices, during other diagnostic and therapeutic intravascular procedures. It is not intended for use in the cerebral vasculature.
    Device Description
    The proximal and distal portions of the guide wire are constructed from a core assembly. A series of tapers and flats, which reduce the diameter of the core wire distally, vields the desired tip flexibility. The distal 12 to 15 centimeters proximal to the tip of the ACS HI-TOROUE IRON MAN™ Guide Wire are coated with Microglide® while the remaining portion is coated with polytetrafluoroethylene (PTFE). Both coatings are intended to reduce friction for improved movement of the wire within the catheter. The platinum alloy coils provide the physicians with a radiopaque tip.
    Ask a Question
    K Number
    K962495
    Device Name
    INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115 ROTATING HEMOSTATIC VALVE)
    Manufacturer
    ADVANCED CARDIOVASCULAR SYSTEMS, INC.
    Date Cleared
    1996-09-12

    (78 days)

    Product Code
    MAV
    Regulation Number
    870.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED CARDIOVASCULAR SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The INDEFLATOR PLUS 30™ Inflation Device is recommended for use during vascular procedures in conjunction with interventional devices such as balloon catheters to create and monitor pressure in the balloon catheter. The PLUS 30 PRIORITY PACKTM: INDEFLATOR PLUS 30TM Inflation Device- See description above. PLUS 30 PRIORITY PACK™ Accessory Kit- The Accessory Kit is recommended for use during vascular procedures in conjunction with interventional and/or diagnostic devices (e.g., balloon dilatation catheters, artherectomy devices, stent delivery systems, intravascular ultrasound devices.)
    Device Description
    INDEFLATOR PLUS 30™ Inflation Device is a manually operated device used to pressurize and depressurize balloon catheters. Pressure can be monitored via a pressure gauge. The PLUS 30 PRIORITY PACK™ is comprised of the INDEFLATOR PLUS 30™ inflation device packaged with accessories used during vascular procedures in conjunction with interventional or diagnostic devices. These accessories include a torque device, a guide wire introducer and a rotating hemostatic valve.
    Ask a Question
    K Number
    K961471
    Device Name
    INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 ROTATING HEMOSTATIC VALVE)
    Manufacturer
    ADVANCED CARDIOVASCULAR SYSTEMS, INC.
    Date Cleared
    1996-05-08

    (21 days)

    Product Code
    MAV
    Regulation Number
    870.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED CARDIOVASCULAR SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    INDEFLATOR 20/30™ Inflation Device- The INDEFLATOR 20/30™ Inflation Device is recommended for use during cardiovascular procedures in conjunction with interventional devices such as balloon catheters to create and monitor pressure in the balloon catheter. 20/30 PRIORITY PACK™ Accessory Kit- The Accessory Kit is recommended for use during cardiovascular procedures in conjunction with interventional and/or diagnostic devices (e.g., balloon dilatation catherectomy devices, stent delivery systems, intravascular ultrasound devices.)
    Device Description
    The INDEFLATOR 20/30™ Inflation Device is a manually operated device used to pressurize and depressurize balloon catheters. Pressure can be monitored via a pressure gauge. The 20/30 PRIORITY PACK™ is comprised of the INDEFLATOR 20/30™ inflation device packaged with accessories used during vascular procedures in conjunction with interventional or diagnostic devices. These accessories include a torque device, a guide wire introducer and a rotating hemostatic valve.
    Ask a Question
    K Number
    K955175
    Device Name
    ACS ANCHOR EXCHANGE DEVICE
    Manufacturer
    ADVANCED CARDIOVASCULAR SYSTEMS, INC.
    Date Cleared
    1996-04-05

    (144 days)

    Product Code
    DQX
    Regulation Number
    870.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED CARDIOVASCULAR SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ACS ANCHORTM Exchange Device is used within a guiding catheter to facilitate the exchange of an interventional device while maintaining the position of a guide wire within the vasculature.
    Device Description
    The ACS ANCHORTM Exchange Device consists of a proximal control handle and a superelastic core wire within a single lumen hypotube approximately 96 cm. long. The control handle provides the userinterface to control the movement of the hypotube and the core wire. During an exchange procedure, the distal end of the core wire is wrapped around the guide wire to lock its position in the vasculature. The ACS ANCHOR™ Exchange Device is compatible with 0.010" through 0.018" diameter non-hydrophilic-coated guide wires and associated interventional devices (except the ROTOBLATOR® Rotational Angioplasty System) when at least 0.015" free space is available within the guiding catheter.
    Ask a Question

    Page 1 of 1