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510(k) Data Aggregation

    K Number
    K062214
    Device Name
    BRACHYSCIENCES STRANDPORT
    Manufacturer
    WORLDWIDE MEDICAL TECHNOLOGIES, LLC
    Date Cleared
    2007-03-01

    (212 days)

    Product Code
    KXK
    Regulation Number
    892.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    WORLDWIDE MEDICAL TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The World Wide Medical Technologies StrandPort intended use is to provide a disposable carrier for seed strands containing radionuclide seeds for the introduction by the user of radionuclide seeds into Prostate Seeding Needles for brachytherapy procedures.
    Device Description
    disposable carrier for seed strands containing radionuclide seeds
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    K Number
    K023179
    Device Name
    READI-STRAND, MODEL PSSTRAND
    Manufacturer
    WORLDWIDE MEDICAL TECHNOLOGIES, LLC
    Date Cleared
    2003-07-02

    (281 days)

    Product Code
    KXK
    Regulation Number
    892.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    WORLDWIDE MEDICAL TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Worldwide Medical Technologies Readi-Strand intended use is to provide a carrier for radionuclide seeds during the introduction of radionuclide seeds into the body for Brachytherapy procedures. The anatomical site is typically the transperineal approach in and around the prostate gland.
    Device Description
    Not Found
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    K Number
    K022705
    Device Name
    READI-STRAND, MODEL PSSTRAND
    Manufacturer
    WORLDWIDE MEDICAL TECHNOLOGIES, LLC
    Date Cleared
    2003-06-09

    (299 days)

    Product Code
    KXK
    Regulation Number
    892.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    WORLDWIDE MEDICAL TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Worldwide Medical Technologies Readi-Strand intended use is to provide a carrier for radionuclide seeds during the introduction of radionuclide seeds into the body for Brachytherapy procedures.
    Device Description
    Not Found
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    K Number
    K022389
    Device Name
    READI-LOAD SYSTEM, MODEL PSS 1820RL
    Manufacturer
    WORLDWIDE MEDICAL TECHNOLOGIES, LLC
    Date Cleared
    2003-05-06

    (287 days)

    Product Code
    KXK
    Regulation Number
    892.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    WORLDWIDE MEDICAL TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Worldwide Medical Technologies Readi-Load intended use is to provide a pre-sterilized needle carrier for radionuclide seeds for the introduction of radionuclide seeds into the body for Brachytherapy procedures.
    Device Description
    Not Found
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    K Number
    K020641
    Device Name
    SPIRITUS(TM) RESPIRATORY SYSTEM #SRS 001
    Manufacturer
    WORLDWIDE MEDICAL TECHNOLOGIES, LLC
    Date Cleared
    2002-10-29

    (244 days)

    Product Code
    BZD
    Regulation Number
    868.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    WORLDWIDE MEDICAL TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Spiritus™ Respiratory System is a patient interface accessory intended for use with devices that administer CPAP (continuous positive airway pressure) and bi-level airway pressure in treating adult patients. The Spiritus™ Respiratory System is a single-patient interface accessory intended for use by patients who have been prescribed positive airway pressure treatment (PAP) including CPAP and BiPAP.
    Device Description
    The device is a single-patient-use, patient interface accessory for patients receiving positive airway pressure treatment including CPAP and BiPAP and comprises the nasal/tubing assembly and associated headgear. The nasal cannula protuberances fit into the patient's nares effecting a substantially artight seal, facilitating the delivery of the positive airway pressure. Tubing is fitted to the nasal cannula via elbow connectors which may be used to secure the detachable headgear. The tubing fits to a "Y" connector to effect connection to the flow generator output tube. The nasal cannula, tubing and connectors may be cleaned with mild soap and water for use by the same patient.
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    K Number
    K020337
    Device Name
    READI-STRAND; MODEL PSSTRAND
    Manufacturer
    WORLDWIDE MEDICAL TECHNOLOGIES, LLC
    Date Cleared
    2002-07-29

    (178 days)

    Product Code
    KXK
    Regulation Number
    892.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    WORLDWIDE MEDICAL TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Worldwide Medical Technologies Readi-Strand intended use is to provide a carrier for radionuclide seeds during the introduction of radionuclide seeds into the body for Brachytherapy procedures. The anatomical site is typically the transperineal approach in and around the prostate gland.
    Device Description
    Not Found
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    K Number
    K020867
    Device Name
    BONE MARROW ASPIRATION NEEDLE, MODEL BMB1110J, BONE MARROW HARVEST NEEDLE, MODEL BMHN1104VX, & BONE MARROW BIOPSY NEEDL
    Manufacturer
    WORLDWIDE MEDICAL TECHNOLOGIES, LLC
    Date Cleared
    2002-05-20

    (63 days)

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

    WORLDWIDE MEDICAL TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Worldwide Medical Technologies Bone Marrow Aspiration/Core Needle is to obtain samples of aspirates and bone marrow for cytologic and histologic examination in the diagnosis and treatment of various diseases. The samples are typically taken by percutanious puncture of the posterior iliac crest of the pelvic bone.
    Device Description
    Worldwide Medical Technologies AspirCore
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    K Number
    K991344
    Device Name
    WORLDWIDE MEDICAL TECHNOLOGIES SEEDING SPACERS
    Manufacturer
    WORLDWIDE MEDICAL TECHNOLOGIES, LLC
    Date Cleared
    1999-11-05

    (200 days)

    Product Code
    KXK
    Regulation Number
    892.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    WORLDWIDE MEDICAL TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Worldwide Medical Technologies Seeding Spacers intended use is to provide space between radionuclide seeds during the introduction of radionuclide seeds into the body for Brachytherapy procedures. The anatomical site is typically the transperineal approach for radionuclide seed application in and around the prostate.
    Device Description
    Not Found
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    K Number
    K981889
    Device Name
    WORLDWIDE MEDICAL TECHNOLOGIES INTRODUCER NEEDLE
    Manufacturer
    WORLDWIDE MEDICAL TECHNOLOGIES, LLC
    Date Cleared
    1998-07-31

    (63 days)

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

    WORLDWIDE MEDICAL TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use for the Worldwide Medical Technologies Introducer Needle for Biopsy Needles is in the co-axial biopsy technique where the introducer needle is first percutaneously placed at the site of the lesion and the biopsy needle is placed through the introducer to take the sample. This allows for accurate multiple sampling of the same lesion. This technique is used in any of the soft tissue organs of the abdomen and thorax.
    Device Description
    Worldwide Medical Technologies Introducer Needle for Biopsy Needles
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    K Number
    K982097
    Device Name
    WORLDWIDE MEDICAL TECHNOLOGIES INTRACERVICAL BLOCK NEEDLE, MODEL TBD
    Manufacturer
    WORLDWIDE MEDICAL TECHNOLOGIES, LLC
    Date Cleared
    1998-06-25

    (10 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    WORLDWIDE MEDICAL TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use for the Worldwide Medical Technologies Intracervical Block Needle is to inject anesthetic in the cervical area.
    Device Description
    Worldwide Medical Technologies Intracervical Block Needle
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