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510(k) Data Aggregation

    K Number
    K101832
    Device Name
    BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT
    Manufacturer
    MEDICAL DEVICE TECHNOLOGIES, INC.
    Date Cleared
    2010-08-27

    (57 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL DEVICE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The automatic BioPince™ Ultra Full Core Biopsy Instrument is intended for multiple percutaneous full-core sampling of soft tissue, tumors, or masses for histological analysis. Soft tissue sampling includes, but is not limited to, kidney, liver, breast, prostate and various soft tissue lesions.
    Device Description
    The BioPince™ Ultra Full Core Biopsy Instrument is an automatic, disposable biopsy instrument that cuts a full core specimen of soft tissue. The instrument is designed to expel the specimen upon re-cocking of the instrument which prepares the instrument for taking another sample (i.e., ready to be fired). The instrument has two firing trigger buttons with an indicator window and safety button. The instrument is available in 14G, 16G, 18G and 20G needle sizes and 10cm, 15cm and 20cm lengths.
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    K Number
    K053518
    Device Name
    INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR
    Manufacturer
    MEDICAL DEVICE TECHNOLOGIES, INC.
    Date Cleared
    2006-01-26

    (38 days)

    Product Code
    NEU
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL DEVICE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The InterV brand V-Mark Breast Biopsy Site Marker with Titanium Anchor is intended to mark tissue during a percutaneous breast biopsy procedure, be visible under MRI and ultrasound for at least 6 weeks, and be permanently visible by fluoroscopy.
    Device Description
    The V-Mark Breast Biopsy Site Marker is made of a resorbable copolymer, a polyester derivative of lactic and glycolic acids. Polylactic/polyglycolic acid copolymers degrade and resorb in vivo by hydrolysis into lactic and glycolic acids, which are then metabolized by the body. The site markers are deployed through an applicator that fits in commercially available biopsy probes. The V-Mark Breast Biopsy Site Marker marks the site of biopsy tissue sample, and is visible for up to 6 weeks by x-ray, ultrasound and MRI. The body then metabolizes the marker over time. The V-Mark contains a titanium component for permanent radiographic visibility. The V-Mark Breast Biopsy Site Marker has been modified to remove the contrast agent that was incorporated into the polymer to provide radiopacity. The titanium component of the device provides for permanent radiographic visibility, eliminating the need for contrast agent in the resorbable polymer. V-Mark Breast Biopsy Site Markers are made of 75/25% poly(D,L-lactide-co-glycolide) copolymer. No other changes have been made to the formulation other than the elimination of the contrast agent. The site markers are deployed into the biopsy needle tract using a hand held applicator with a two finger-push control rod that delivers a single marker. The site markers are deployed through an applicator that fits commercially available biopsy probes or coaxial needles including the J&J Ethicon Mammotome biopsy probe, the Pro-Mag Coaxial Introducer with Blunt Obturator, the Bio-Pince Co-axial Introducer with Blunt Obturator, the Medical Device Technologies V-Core Co-axial Introducer, and the Suros Vacuum Assisted Biopsy System. For physicians who desire to perform biopsy under ultrasound guidance, a delivery system cannula with an echogenic tip is also available for multiple coaxial applications.
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    K Number
    K051421
    Device Name
    INTER V BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR
    Manufacturer
    MEDICAL DEVICE TECHNOLOGIES, INC.
    Date Cleared
    2005-08-30

    (90 days)

    Product Code
    NEU
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL DEVICE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The InterV brand V-Mark Breast Biopsy Site Marker with Titanium Anchor is intended to mark tissue during a percutaneous breast biopsy procedure, be visible under MRI and ultrasound for at least 6 weeks, and be permanently visible by fluoroscopy.
    Device Description
    The V-Mark biopsy site marker is made of two components; a resorbable copolymer, a polyester derivative of lactic and glycolic acids, and a titanium anchor. Polylactic/polyglycolic acid copolymers degrade and resorb in vivo by hydrolysis into lactic and glycolic acids, which are then metabolized by the body. The titanium anchor provides a permanent component to the marker of the biopsy site. The site markers are deployed through an applicator that fits commercially available biopsy probes or coaxial needles including the J&J Ethicon Mammotome 11 gauge biopsy probe, the Pro-Mag Coaxial Introducer with Blunt Obturator, the Bio-Pince Co-axial Introducer with Blunt Obturator, and the Medical Device Technologies V-Core Co-axial Introducer. The V-Mark device marks the site of biopsy tissue sample, and is visible for up to 6 weeks by x-ray, ultrasound and MRI. The body then metabolizes the copolymer portion of the marker over time. The titanium anchor provides permanent radiographic visibility.
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    K Number
    K050873
    Device Name
    CANALIZER HYDROPHILIC GUIDE WIRE
    Manufacturer
    MEDICAL DEVICE TECHNOLOGIES, INC.
    Date Cleared
    2005-05-26

    (50 days)

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

    MEDICAL DEVICE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CanaliZer Hydrophilic Guide Wire is designed for use in the peripheral vasculature with medical devices requiring a 0.035" or 0.038" outer diameter guidewire. The CanaliZer is not intended for use in the coronary arteries.
    Device Description
    The guidewires are constructed from a Nitinol core coated with Tecoflex EG85-A polyurethane to provide a wire with a maximum OD of 0.035" or 0.038". The polyurethane formulation contains BaSO4 for radiopacity. A hydrophilic coating is applied to the distal portion of the guidewire to facilitate wire movement within 0.035" or 0.038" diameter devices. The guidewires are available in lengths of 150, 180 and 260 cm. Two tip shapes are also available, straight and angled. Both tip shapes are provided on wires of standard stiffness, and a stiffer design. The family of guidewires has a CE mark and is in commercial distribution in Europe.
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    K Number
    K043523
    Device Name
    INTERV BRAND SNARELOK BONE MARROW BIOPSY NEEDLE
    Manufacturer
    MEDICAL DEVICE TECHNOLOGIES, INC.
    Date Cleared
    2005-02-11

    (53 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL DEVICE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SnareLok Bone Marrow Biopsy Needle is intended for harvesting bone and/or bone marrow specimens.
    Device Description
    The biopsy instrument is a sterile disposable device which features a cannula assembly containing an outer cannula with an inner spiral snare tube at the distal tip. The device has a handle with a snare lever that can be rotated 180° to engage the snare when a biopsy sample needs to be taken. Finally the device has a stationary stylet to prevent coring during advancement, and a stylet cap which mates to the handle. Three sizes are available; 8, 11 and 13 gauge needles. The 8 and 11 gauge needles are sold in 4" and 6" lengths and have a tip configuration identical to the geometry of the existing Medical Device Technologies Manan Bone and Bone Marrow Biopsy Needle. The 13 gauge needles are sold in 2" and 3" lengths and have a less tapered tip configuration identical to a bone marrow needle currently manufactured by Ranfac.
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    K Number
    K042464
    Device Name
    V-CORE FULL CORE BREAST BIOPSY INSTRUMENT
    Manufacturer
    MEDICAL DEVICE TECHNOLOGIES, INC.
    Date Cleared
    2004-09-30

    (17 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL DEVICE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K040427
    Device Name
    FIBREX CATHETER PATENCY DEVICE
    Manufacturer
    MEDICAL DEVICE TECHNOLOGIES, INC.
    Date Cleared
    2004-05-03

    (74 days)

    Product Code
    FOZ
    Regulation Number
    880.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL DEVICE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fibrex™ Catheter Patency Device is intended to disrupt fibrin sheath formation on both the external and internal surface of vascular access catheters, thus restoring functional patency.
    Device Description
    The Fibrex™ Catheter Patcncy Device is a tri-axial delivery catheter assembly comprised of an outer catheter storing an inner guide structure and an inner stripping coil. The inner guide structure is for directing and guiding the stripping coil through the catheter to the free end of the catheter and back up around the exterior surface of the vascular catheter. The stripping coil is formed of a shape memory or super-elastic material, wherein the stripping coil is preformed to assume a helical shape wrapping about the outer surface of the vascular catheter in a manner providing for the stripping of build-up from the outer surface of the vascular catheter when the stripping coil is moved relative to the vascular catheter. The tri-axial delivery catheter assembly is attached to an injection molded plastic hand assembly that controls the movement of the guide catheter and subsequent insertion of the stripping coil. The delivery catheter assembly is adapted for selectively coupling to a luer connector secured to the venous lumen of a traditional vascular catheter. The outer catheter of the Fibrex™ device is made from a biocompatible Polyimid/PTFF. composite. The inner dual lumen tube is made from nylon. A Nitinol wire is housed in one lumen of the guide curve catheter to provide directional memory for the actuation and operation of the Nitinol stripping coil . Both the outer catheter and the guide catheter contain distal marking bands made from gold.
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    K Number
    K031442
    Device Name
    PBN GUIDEWIRES
    Manufacturer
    MEDICAL DEVICE TECHNOLOGIES, INC.
    Date Cleared
    2003-08-13

    (99 days)

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

    MEDICAL DEVICE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PBN Guidewires are intended for use to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.
    Device Description
    The PBN Guidewires are made from a stainless steel or nitinol core wire surrounded by a stainless steel or tungsten spring. The PBN Guidewires will be provided uncoated, hydrophilic coated, or PTFE coated. The PBN Guidewires will be provided in the following diameters and lengths: .018 in. and .020 in. diameter, and 40 cm to 300 cm in length.
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    K Number
    K021606
    Device Name
    EN-SNARE ENDOVASCULAR SNARE AND CATHETER
    Manufacturer
    MEDICAL DEVICE TECHNOLOGIES, INC.
    Date Cleared
    2002-05-31

    (15 days)

    Product Code
    MMX
    Regulation Number
    870.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL DEVICE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The En-Snare™ Endovascular Snare and Catheter is intended for use in the cardiovascular system or hollow viscous to retrieve and manipulate foreign objects. Manipulation procedures include indwelling venous catheter repositioning, indwelling venous catheter fibrin sheath stripping, and central venous access veni-puncture procedure assistance.
    Device Description
    The En-Snare™ Endovascular Snare and Catheter is comprised of stranded nitinol/platinum cables mechanically secured to a nitinol wire inserted into an intravascular catheter and manipulated by use of an external pin vise. The catheter is made from biocompatible FPE that has been used extensively in intravascular catheters.
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    K Number
    K011790
    Device Name
    MICROCRUISER PLUS INTRODUCER SET
    Manufacturer
    MEDICAL DEVICE TECHNOLOGIES, INC.
    Date Cleared
    2001-09-05

    (89 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL DEVICE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MicroCruiser® Plus Introducer Set is intended for use in the introduction and placement of guidewires and/or catheters.
    Device Description
    The MicroCruiser® Plus Introducer Set is comprised of an .018" diameter guidewire, a guidewire introducer needle, and a coaxial introducer that has a diameter suitable for catheter introduction and placement. The introducer tubing is made from biocompatible polyurethane that has been used extensively in both short and long term catheters. The introducers are provided in the following French sizes: 3 (Inner)/4 (Outer), 3 (Inner)/5 (Outer), and 4 (Inner)/6 (Outer), and in lengths of 10 cm.
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