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510(k) Data Aggregation

    K Number
    K983409
    Device Name
    V-CATH PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) SEE APPENDIX 1
    Manufacturer
    HDC CORP.
    Date Cleared
    1998-10-16

    (18 days)

    Product Code
    FOZ
    Regulation Number
    880.5200
    Type
    Special
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    V-CATH PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) SEE APPENDIX 1

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The V-Cath® PICC is indicated for the patient that requires repeated access for infusion or injection therapy. It can also be used for blood sampling although a 3.8FR or larger catheter is recommended.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information available about acceptance criteria, device performance metrics, or any studies conducted to prove the device meets specific criteria.

    The text is a 510(k) clearance letter from the FDA for the V-Cath® PICC. This letter confirms that the device is substantially equivalent to a predicate device and can be marketed. It discusses regulatory matters, product classification, and general controls, but it does not contain any data, results, or details of studies regarding the device's performance against specific acceptance criteria.

    Therefore, I cannot populate the table or answer the specific questions you've posed as the necessary information is not present in the provided document. The document only states the "Indications for Use" of the device.

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