Search Filters

Search Results

Found 4 results

510(k) Data Aggregation

    K Number
    K140085
    Device Name
    UNIVERSA PERCULTANEOUS DRAINAGE CATHETER
    Manufacturer
    COOK INCORPORATED
    Date Cleared
    2014-11-18

    (309 days)

    Product Code
    FEW, KOB, LJE
    Regulation Number
    876.5090
    Why did this record match?
    Product Code :

    FEW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Universa® Loop Drainage Catheter Set is intended to provide percutaneous urine drainage from the genitourinary system. The Universa® Malecot Drainage Catheter Set is intended to provide percutaneous urine drainage from the genitourinary system.
    Device Description
    The Universa® Percutaneous Drainage Catheter Sets include introductory and exchange sets available with either a loop (6-14 Fr) or a Malecot catheter (8-24 Fr). Suprapubic sets are available with a Malecot catheter (8-16 Fr). Each set includes a drainage catheter and connecting tube, and may also include straightening stylets, trocar needle with obturator, hollow needle, wire guide, dilators, silicone retention disc with pull tie, or one-way stopcock. The devices will be supplied sterile and intended for one-time use.
    Ask a Question
    K Number
    K070879
    Device Name
    BARD MALECOT AND PEZZER DRAINS
    Manufacturer
    C.R. BARD, INC.
    Date Cleared
    2007-04-24

    (25 days)

    Product Code
    FEW
    Regulation Number
    876.5090
    Why did this record match?
    Product Code :

    FEW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bard malecot and pezzer drains are intended for use in the drainage of urine. The drains are inserted suprapubically into the bladder or through a nephrostomy tract.
    Device Description
    The drains are composed of a straight or angled, single lumen catheter shaft. The proximal end, which remains external to the patient, is a funnel for connection to a urine collection device. The funnel is printed with a product code, date code, product type and French size, The distal end, which is placed in the patient, is offered in various configurations including whistle tip, 2-wing, 4-wing, retention head with drainage eyes or open end retention head. The entire drain is composed of natural rubber latex.
    Ask a Question
    K Number
    K981258
    Device Name
    MANAN MALECOT BASKET DRAINAGE CATHETER
    Manufacturer
    MEDICAL DEVICE TECHNOLOGIES, INC.
    Date Cleared
    1998-04-22

    (16 days)

    Product Code
    FEW
    Regulation Number
    876.5090
    Why did this record match?
    Product Code :

    FEW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Manan™ Malecot Basket Drainage Catheter is for percutaneous nephrostomy and abcess drainage.
    Device Description
    Manan drainage catheters are made from a biocompatible urethane (Tecoflex) that has been used extensively in both short and long term implantable medical devices. This material softens at body temperature thus minimizing tissue trauma. The catheters come in malecot end configuration. Also included with the catheters are flexible stiffening cannula.
    Ask a Question
    K Number
    K954147
    Device Name
    MANAN MALECOT BASKET DRAINAGE CATHETER
    Manufacturer
    MANAN MEDICAL PRODUCTS, INC.
    Date Cleared
    1996-03-26

    (203 days)

    Product Code
    FEW
    Regulation Number
    876.5090
    Why did this record match?
    Product Code :

    FEW

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

    Page 1 of 1