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510(k) Data Aggregation

    K Number
    K990707
    Device Name
    MEDTRONIC 5F & 9F ZUMA GUIDING CATHETERS
    Manufacturer
    MEDTRONICS INTERVENTIONAL VASCULAR
    Date Cleared
    1999-03-22

    (18 days)

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

    MEDTRONICS INTERVENTIONAL VASCULAR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medtronic® Zuma™ Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The Zuma™ catheter is intended to be used in the coronary or peripheral vascular system.
    Device Description
    The Medtronic® Zuma™ Guiding Catheters will be available in 5F 9F outer diameters. The 6F and 9F (non-segmented) catheter is constructed with a braided proximal shaft with an inner liner and a soft distal tip. The 5F, 7F, 8F and 9F(segmented) Zuma catheters are manufactured with a braided proximal shaft and segments, an inner liner and a soft distal tip. The inner lumen of the Zuma™ catheter has a thin lubricious coating. The Zuma™ Guiding Catheter (6F - 9F) has a larger inner lumen diameter than its predicate devices. The 5F Zuma is comparable in stiffness to a 6F predicate device.
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    K Number
    K980973
    Device Name
    MEDTRONIC ANGIOGRAPHIC CATHETER
    Manufacturer
    MEDTRONICS INTERVENTIONAL VASCULAR
    Date Cleared
    1998-12-10

    (269 days)

    Product Code
    DQO
    Regulation Number
    870.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRONICS INTERVENTIONAL VASCULAR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medtronic® Angiographic Catheter is designed to be used for delivering radiopaque media and making pressure measurements in selected coronary sites within the vascular system.
    Device Description
    The Medtronic® Angiographic Catheters are 4F, 5F, 6F and 7F in diameter with a braided proximal shaft, non-braided distal segment and a variety of tip configurations.
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    K Number
    K982883
    Device Name
    MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER
    Manufacturer
    MEDTRONICS INTERVENTIONAL VASCULAR
    Date Cleared
    1998-09-04

    (18 days)

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

    MEDTRONICS INTERVENTIONAL VASCULAR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medtronice ZumaTM Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The Zuma™ catheter is intended to be used in the coronary or peripheral vascular system
    Device Description
    The Medtronic® Zuma™ Guiding Catheters will be available in 6F, 7F and 8F outer diameters. The 6F catheter is constructed with a braided proximal shaft with an inner liner and a soft distal tip. The 7F and 8F catheters are manufactured with a braided proximal and segmented shaft with an inner liner and a soft distal tip. The inner lumen of the 22ma™ catheter (6F-8F) has a thin lubricious coating. The Zuma™ Guiding Catheter has a larger inner lumen diameter and a stiffer shaft than its predicate devices.
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    K Number
    K981198
    Device Name
    MEDTRONIC ZUMA GUIDING CATHETER
    Manufacturer
    MEDTRONICS INTERVENTIONAL VASCULAR
    Date Cleared
    1998-08-07

    (127 days)

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

    MEDTRONICS INTERVENTIONAL VASCULAR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medtronic® Zuma™ Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended to be used in the coronary or peripheral vascular system.
    Device Description
    The Medtronic® Zuma™ Guiding Catheters will be available in a 6F outer diameter size. The catheter is constructed with a braided proximal shaft with an inner liner and a soft distal tip. The inner lumen of the catheter has a thin lubricious coating. The Zuma™ Guiding Catheter has a larger inner lumen diameter and a stiffer shaft.
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    K Number
    K972944
    Device Name
    MEDTRONIC MUSTANG SUPER FLOPPY GUIDE WIRE/FLOPPY GUIDE WIRE/INTERMEDIATE GUIDE WIRE/STANDARD GUIDE WIRE/EXTRA SUPPORT
    Manufacturer
    MEDTRONICS INTERVENTIONAL VASCULAR
    Date Cleared
    1997-11-03

    (84 days)

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

    MEDTRONICS INTERVENTIONAL VASCULAR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mustang™ Steerable Guide Wire is indicated for use in introducing and placing interventional catheters during percutaneous transluminal coronary angioplasty (PTCA) and/or percutaneous transluminal angioplasty (PTA).
    Device Description
    The Medtronic® MUSTANG™ Steerable Guide Wire is a quide wire having a maximum diameter of 0.014" (0.36 mm). The proximal shaft is coated with a polymer and the distal 33 cm contains a lubricious coating. The distal segment of the wire contains a spring which is radiopaque. The MUSTANG™ is provided sterile, and is intended for one procedure use only (disposable).
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    K Number
    K961917
    Device Name
    MEDTRONIC MUSTANG STEERABLE GUIDE WIRE (M-45FR, M45FX)
    Manufacturer
    MEDTRONICS INTERVENTIONAL VASCULAR
    Date Cleared
    1996-11-20

    (187 days)

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

    MEDTRONICS INTERVENTIONAL VASCULAR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medtronic® MUSTANG™ Steerable Guide Wire is for use in introducing and placing interventional catheters during percutaneous transluminal coronary angioplasty (PTCA) and/or percutaneous transluminal angioplasty (PTA).
    Device Description
    The Medtronic® MUSTANG™ Steerable Guide Wire is a guide wire having a maximum diameter of 0.014" (0.36 mm). The proximal shaft is coated with a polymer and the distal 33 cm contains a lubricious coating. The distal segment of the wire contains a spring which is radiopaque. The MUSTANG™ is provided sterile, and is intended for one procedure use only (disposable).
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    K Number
    K960983
    Device Name
    MEDTRONIC EVERST 30 INFLATION DEVICE/SURVIVAL KIT
    Manufacturer
    MEDTRONICS INTERVENTIONAL VASCULAR
    Date Cleared
    1996-05-30

    (80 days)

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

    MEDTRONICS INTERVENTIONAL VASCULAR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Indications for the Medtronic® Everest™ 30 Inflation Device / Survival Kit are identical to those for commercially available inflation devices. The devices are used for the inflation / deflation of balloon dilatation catheters. These devices are intended for single use.
    Device Description
    The Medtronic® Everest™ 30 Inflation Device is a sterilized, single use device intended as an accessory to balloon dilatation catheters. The Everest™ 30 Inflation Device will be used to inflate and deflate balloon dilatation catheters during angioplasty procedures. The device contains an analog pressure gauge which will read the inflation pressure of the balloon catheter. The pressure gauge is isolated from the syringe fluid with use of a bouron tube and is graduated in 0.5 atmosphere / bar increments to a 30 atmosphere / bar maximum. The device has a twenty (20) cubic centimeter syringe to hold a contrast medium for balloon inflation. The device has a plunger engaging mechanism. When engaged, the plunger, which applies contrast medium to the syringe, is rotated in a clockwise direction by the user to slowly increase the syringe pressure or in a counter clockwise direction to slowly decrease the syringe pressure. When disengaged, the plunger can be manually retracted to rapidly apply vacuum and advanced to rapidly apply syringe pressure. The inflation device is connected to the balloon catheter manifold via a high pressure connecting tube which terminates into a male luer fitting. The inflation device also contains an accessory three way stopcock for preparation procedures. The inflation device may also be provided as a Survival Kit. The Survival Kit includes one (1) Y -Adapter with Hemostasis Valve, one (1) Guide Wire Introducer and one (1) Guide Wire Torque Handle.
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    K Number
    K955651
    Device Name
    MEDTRONIC SHERPA GUIDING CATHETER
    Manufacturer
    MEDTRONICS INTERVENTIONAL VASCULAR
    Date Cleared
    1996-01-22

    (41 days)

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

    MEDTRONICS INTERVENTIONAL VASCULAR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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