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510(k) Data Aggregation

    K Number
    K002276
    Device Name
    PSI SKULL CLAMP
    Manufacturer
    V. MUELLER NEURO/SPINE
    Date Cleared
    2000-08-29

    (34 days)

    Product Code
    HBL
    Regulation Number
    882.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    V. MUELLER NEURO/SPINE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993019
    Device Name
    PACIFIC SURGICAL PATTIES
    Manufacturer
    V. MUELLER NEURO/SPINE
    Date Cleared
    2000-03-30

    (204 days)

    Product Code
    HBA
    Regulation Number
    882.4700
    Why did this record match?
    Applicant Name (Manufacturer) :

    V. MUELLER NEURO/SPINE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To be used in surgery to protect nervous tissue, absorb fluids, or stop bleeding.
    Device Description
    A cotton pad used during surgery to protect nervous tissue, absorb fluids or stop bleeding.
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    K Number
    K991959
    Device Name
    PSI TITANIUM ANEURYSM CLIP
    Manufacturer
    V. MUELLER NEURO/SPINE
    Date Cleared
    2000-01-06

    (210 days)

    Product Code
    HCH, HCI
    Regulation Number
    882.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    V. MUELLER NEURO/SPINE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Permanent placement in the brain for occlusion of cerebral aneurysms. They are only to be applied with PSI clip appliers with titanium alloy jaw inserts
    Device Description
    Bent titanium wire which provides a spring operated, self Closing aneurysm clip of various lengths/sizes.
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    K Number
    K991002
    Device Name
    PSI TITANIUM MICRO-LIGATION HEMOSTATIC CLIP
    Manufacturer
    V. MUELLER NEURO/SPINE
    Date Cleared
    1999-06-11

    (78 days)

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

    V. MUELLER NEURO/SPINE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Temporary or Permanent Occlusion of Blood Vessels Including Intracranial Blood Vessels
    Device Description
    Bent titanium wire that is forcibly closed to occlude an intracranial blood vessel, stop bleeding, or hold tissue or mechanical device in place in a patient. Especially designed to prevent slippage when properly applied.
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    K Number
    K972750
    Device Name
    TAKA ANEURYSM CLIP
    Manufacturer
    V. MUELLER NEURO/SPINE
    Date Cleared
    1998-07-09

    (351 days)

    Product Code
    HCH, HCI
    Regulation Number
    882.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    V. MUELLER NEURO/SPINE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Temporary occlusion of intracranial blood verssels/aneurysms. Permanent placement in the brain for occlusion of aneurysms.
    Device Description
    Not Found
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    K Number
    K964402
    Device Name
    VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM
    Manufacturer
    V. MUELLER NEURO/SPINE
    Date Cleared
    1997-01-23

    (80 days)

    Product Code
    GZT
    Regulation Number
    882.4800
    Why did this record match?
    Applicant Name (Manufacturer) :

    V. MUELLER NEURO/SPINE

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

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