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510(k) Data Aggregation

    K Number
    K151363
    Device Name
    Zephyr Vascular Compression Device
    Manufacturer
    ADVANCED VASCULAR DYNAMICS
    Date Cleared
    2015-07-31

    (71 days)

    Product Code
    DXC
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED VASCULAR DYNAMICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Zephyr™ Vascular Compression Devices are indicated for use by medical professionals to promote hemostasis following a catheterization or other puncture into a blood vessel in a patient's arm or leg, including: radial, dorsalis pedis, or tibial blood vessels, arterial or venous line or sheath removal, hemodialysis, and in anticoagulation therapy.
    Device Description
    The Zephyr™ Vascular Compression Devices are external compression devices deployed on a patient's arm or leg to promote hemostasis at a puncture site in a blood vessel. The Zephyr™ devices are single-use, sterile, individually pouched inflatable devices, deployed onto a skin surface by clinicians to help achieve hemostasis for vascular puncture sites in post-procedure patients. Zephyr is available in different lengths, with and without a separate cuff balloon. The strap measures approximately 1.5" x 8.25" (small) or 9.5" (large) and is composed of biocompatible multiple-layer PVC film and PVC tube, and a syringe and valve made of biocompatible thermoplastics. Hook and loop material is used to secure the strap in position. Only the PVC film comes into contact with broken skin.
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    K Number
    K142122
    Device Name
    RADAR VASCULAR COMPRESSION DEVICE
    Manufacturer
    ADVANCED VASCULAR DYNAMICS
    Date Cleared
    2014-12-04

    (122 days)

    Product Code
    DXC
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED VASCULAR DYNAMICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RadAR™ Vascular Compression Devices are indicated for use by medical professionals to promote hemostasis following a catheterization or other puncture into a blood vessel in a patient's arm or leg, including: radial, brachial, dorsalis pedis or tibial blood vessels, arterial or venous line or sheath removal, hemodialysis, and in patients on anticoagulation therapy.
    Device Description
    The RadAR™ Vascular Compression Devices consist of a strap with a housing with controls for device securement and adjustment, and a compression pad. The product is designed to reduce blood flow in the subject blood vessel compressed by the pad, while allowing blood flow in other vessels in the arm or the leg to promote hemostasis at the vascular puncture site. The user can delicately control the compression applied by the device without unfastening it. This allows gradual release of compression as hemostasis occurs and, at the user's discretion, permits blood flow into the compressed blood vessel during puncture site hemostasis. This device is not life supporting or life sustaining. The product is provided individually packaged. It is a sterile, single use device.
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    K Number
    K131571
    Device Name
    AVD RIGHT RADIAL DRAPE
    Manufacturer
    ADVANCED VASCULAR DYNAMICS
    Date Cleared
    2014-01-31

    (246 days)

    Product Code
    KKX
    Regulation Number
    878.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED VASCULAR DYNAMICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AVD Left and Right Radial Drapes are single use sterile devices intended for use by medical professionals as a protective patient covering, such as to isolate a site of surgical incision or vascular puncture from microbial and other contamination. The drapes are attached to the patient in proximity to a vascular puncture site to isolate vascular access punctures from microbial and other contamination during procedures including angiographies and percutaneous interventions.
    Device Description
    The AVD Radial Drapes are composed of a fluid-resistant film layer, an absorbent barrier layer, and an adhesive material that bonds the two layers. The surgical site is accessed through an oval opening in the drape that is surrounded by an adhesive tape to keep the drape in position over the surgical or vascular puncture site. The AVD Drapes are supplied sterile and for single use only. The Drapes are available in both a Left Radial and a Right Radial configuration. They may be sold singly or as part of a procedure pack.
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    K Number
    K093192
    Device Name
    FLOCHEC PHOTO PLETHYSMOGRAPHIC DEVICE
    Manufacturer
    ADVANCED VASCULAR DYNAMICS
    Date Cleared
    2010-02-12

    (126 days)

    Product Code
    JOM
    Regulation Number
    870.2780
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED VASCULAR DYNAMICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To monitor relative blood flow changes distal to the occlusion of a brachial, ulnar, or femoral artery. From the physician history and clinical findings, the person has pain, claudication, or changes in blood flow to the extremity.
    Device Description
    The FloChec Plethysmograph Device (PPG) is similar to the PPG portion of the Hokanson EC-6 but does not include a strain gauge PPG function that is included in the EC-6. The FloChec Sensor is similar to that of the Parks' Mini-Lab which used a single wave length IR emitter in the sensor. The device is not sterile. Use of the FloChec device by a medical practitioner allows visualizing of the blood flow wave forms in the extremities. In viewing the effects on the wave forms as a result of events such as direct external pressure being applied proximal to the sensor.
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    K Number
    K092503
    Device Name
    RADAR VASCULAR COMPRESSION DEVICES
    Manufacturer
    ADVANCED VASCULAR DYNAMICS
    Date Cleared
    2009-11-19

    (97 days)

    Product Code
    DXC
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED VASCULAR DYNAMICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RADAR™ Vascular Compression Devices are indicated for use by medical professionals to promote hemostasis following a catheterization or other puncture into a blood vessel in a patient's arm, including radial artery catheterization, arterial or venous line removal, hemodialysis, and in patients on anticoagulation therapy.
    Device Description
    The RadAR " Vascular Compression Devices are compression devices used on the arm. Each device consists of a strap with a housing, a screw permanently inserted into the housing, and a movable compression pad. The product is designed to reduce blood flow in the blood vessel compressed by the pad while allowing blood flow in other vessels in the arm. The user can delicately control the compression applied by the device without unfastening it. This allows gradual release of compression as hemostasis occurs and, at the user's discretion, permits blood flow in the compressed vessel during puncture site hemostasis. The product is provided individually packaged. It is a sterile, single-use device.
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    K Number
    K090286
    Device Name
    PRESSUREMATE MANUAL FEMORAL ACCESS COMPRESSION DEVICE
    Manufacturer
    ADVANCED VASCULAR DYNAMICS
    Date Cleared
    2009-03-23

    (46 days)

    Product Code
    DXC
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED VASCULAR DYNAMICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is indicated for use to provide hemostasis of the femoral vascular access site during and following catheterization or cannulation procedures.
    Device Description
    The PressureMate™ Compression Assist Handle mates with the SuperComfort™ Discs (K040615) to provide an alternative to the use of mechanical clamping systems or direct hand holding pressure to obtain hemostasis following fernoral vascular catheterization procedures. The PressureMate™ handle itself is an aluminum handle with stainless steel stem. The stem ends in a female connection which mates to the male connector located on the SuperComfort Discs. The handle can not be used without a Disc. The PressureMate™ comes in two designs: i) symmetrical, with both ends symmetrically tapering down at each end and centrally located stem or ii) asymmetrical, with one end tapered smaller than the other end and the stem slightly off center. The handle designs, round with tapered ends, enable better fit to an operator's hand. Use of the handle and disc by a medical practitioner avoids prolonged direct contact with bodily fluids, and alleviates bio-mechanical stress which may occur during traditional direct digital compression of the femoral artery post-cardiac catheterization.
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    K Number
    K072167
    Device Name
    COMFORTPRESS VASCULAR COMPRESSION ASSIST DEVICE
    Manufacturer
    ADVANCED VASCULAR DYNAMICS
    Date Cleared
    2007-09-06

    (31 days)

    Product Code
    DXC
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED VASCULAR DYNAMICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is indicated for use to provide hemostasis of the femoral vascular access site during and following catheterization or cannulation procedures.
    Device Description
    This device handle is similar to the Compass handle, but of a different shape. The ComfortPress device provides an alternative to the use of mechanical clamping systems or direct hand holding pressure to obtain hemostasis following femoral vascular catheterization procedures. The ComfortPress handle mates with the SuperComfort™ Disc, one of which is provided with each handle. The device is provided as sterile, with a SuperComfort disc attached. The handle with the disc is manually positioned at the femoral vascular access site. The medical practitioner then applies holding force sufficient to obtain hemostasis.
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    K Number
    K040615
    Device Name
    COMPRESSAR SUPERCOMFORT DISC AND STRONGARM SUPERCOMFORT SYSTEM
    Manufacturer
    ADVANCED VASCULAR DYNAMICS
    Date Cleared
    2004-06-01

    (84 days)

    Product Code
    DXC
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED VASCULAR DYNAMICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is indicated for use to provide hemostasis of the femoral vascular access site during and following catheterization or cannulation procedures.
    Device Description
    The CompressAR® SuperComfort™ Disc provides an elastomeric insert in the compression pad, and is used with a modified attachment to the CompressAR @ StrongArm™ System to provide a two-step friction fit connection. The elastomer insert contacts the patient skin providing increased friction against the skin. The disk and supporting stand provide a mechanical means of holding external pressure at or near the site of femoral vascular access. Direct pressure is used to obtain and maintain hemostasis, in a similar fashion to direct hand pressure on the access site or at a pressure point.
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