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510(k) Data Aggregation

    K Number
    K093977
    Device Name
    ALLIGATOR-HD RETRIEVAL DEVICE (ARD-HD), MODEL FA-88840-XX
    Manufacturer
    CHESTNUT MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    2010-04-22

    (119 days)

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

    CHESTNUT MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Alligator™-HD Retrieval Device is intended for use in the peripheral, neuro and cardiovasculature for foreign body retrieval.
    Device Description
    The Alligator™-HD Retrieval Device (ARD-HD) is a retriever with grasping jaws attached to the tip of a flexible wire. The device is designed to be used in conjunction with an off-the-shelf 0.21 in. (0.51mm) ID (inner diameter) microcatheter. The grasping jaws and the distal end of the ARD-HD device are made of radio opaque material facilitating fluoroscopic visualization. The ARD-HD is for single use only.
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    K Number
    K091559
    Device Name
    MARKSMANN CATHETER
    Manufacturer
    CHESTNUT MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    2009-09-18

    (113 days)

    Product Code
    KRA
    Regulation Number
    870.1210
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHESTNUT MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Marksman™ Catheter is intended for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the neuro, peripheral and coronary vasculature.
    Device Description
    The Marksman™ Catheter is a variable stiffness, single lumen catheter designed to access small, tortuous vascular areas. The outer surface of the catheter's distal segment is coated with a hydrophilic material to provide lubricity during use. The catheter also incorporates a PTFE liner to facilitate movement of introduction devices passed through its lumen. The Marksman™ Catheter has a radiopaque marker at the distal tip to facilitate fluoroscopic visualization. The distal tip of the catheter is shapeable. The Marksman™ Catheter is provided with various working lengths. The Marksman™ Catheter is for single use only.
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    K Number
    K043580
    Device Name
    ALLIGATOR RETRIEVAL DEVICE (ARD)
    Manufacturer
    CHESTNUT MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    2005-03-24

    (86 days)

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

    CHESTNUT MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Alligator Retrieval Device (ARD) is indicated for the use in retrieval of foreign objects in peripheral and neuro vasculature.
    Device Description
    The Alligator Retrieval Device (ARD) is a retriever with grasping jaws attached to the tip of a flexible wire. The device is designed to be used in conjunction with off-the-shelf 0.21 in. (0.51mm) ID (inner diameter) microcatheter. The grasping jaws and the distal end of the ARD device are made of radio opaque material facilitating fluoroscope visualization. The ARD is for single use only.
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