LogoFDA 510(k) Search
Search Filters

Search Results

Found 11 results

510(k) Data Aggregation

    K Number
    K031997
    Device Name
    MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM
    Manufacturer
    MALLINCKRODT DAR S.R.L.
    Date Cleared
    2003-11-25

    (151 days)

    Product Code
    BSY
    Regulation Number
    868.6810
    Why did this record match?
    Product Code :

    BSY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This closed suction system is indicated for endotracheal / tracheostomy suction of adult and pediatric intubated patients (including neonates). This device is intended for single use only.
    Device Description
    Ty-Care is a suction catheter system that is designed to connect to the endotracheal tube or tracheostomy tube of the patient and remains in place up to 48 hours ("fixed" version). Ty-Care exel is a detachable system and features a suction catheter that must be replaced after 24 hours while the angled connector (elbow) may be replaced after 72 hours of use. If the patient is on mechanical ventilation, this device allows the attending health professional to suction the patient's tracheobronchial secretions without disconnecting the ventilator. Ty-Care exel offers all the advantages of Ty-Care system with the added feature of a rotating patient-access valve.
    Ask a Question
    K Number
    K992902
    Device Name
    AMBU HAND POWER SUCTION PUMP
    Manufacturer
    AMBU, INC.
    Date Cleared
    1999-10-25

    (56 days)

    Product Code
    BSY, BYY, KTR
    Regulation Number
    868.6810
    Why did this record match?
    Product Code :

    BSY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ambu Suction Pump is intended for quick suction of fluids from the nose and mouth of children and adult as well as for amnionic fluids from the newborn.
    Device Description
    Not Found
    Ask a Question
    K Number
    K982945
    Device Name
    DUAL PURPOSE CLOSED CATHETER
    Manufacturer
    SPIRIT MEDICAL SYSTEMS, INC.
    Date Cleared
    1998-09-22

    (32 days)

    Product Code
    BSY
    Regulation Number
    868.6810
    Why did this record match?
    Product Code :

    BSY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Spirit Medical Systems, Inc. DUAL PURPOSE CLOSED CATHETER is a disposable sterile dual purpose catheter designed to provide both the functions of suctioning and supplying oxygen into the patient's trachea through an endotracheal tube. The first function provides maximum suction efficiency into the airway without compromising sterility and patient safety. The second function provides additional gas flow into the airway for the purpose of improving alveolar ventilation prior to and immediately following suctioning.
    Device Description
    The Spirit Medical Systems, Inc. DUAL PURPOSE CLOSED CATHETER is a disposable sterile dual purpose catheter designed to provide both the functions of suctioning and supplying oxygen into the patient's trachea through an endotracheal tube. The first function provides maximum suction efficiency into the airway without compromising sterility and patient safety. The second function provides additional gas flow into the airway for the purpose of improving alveolar ventilation prior to and immediately following suctioning.
    Ask a Question
    K Number
    K981910
    Device Name
    SUCTION CATHETER
    Manufacturer
    NI-MED, INC.
    Date Cleared
    1998-08-24

    (84 days)

    Product Code
    BSY
    Regulation Number
    868.6810
    Why did this record match?
    Product Code :

    BSY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the NI-MED suction catheter kit is for the physician to aspirate liquids or semi-solids from a patient's upper airway.
    Device Description
    Not Found
    Ask a Question
    K Number
    K972258
    Device Name
    HI-CARE CLOSED SUCTION SYSTEM
    Manufacturer
    MALLINCKRODT MEDICAL
    Date Cleared
    1997-12-29

    (195 days)

    Product Code
    BSY
    Regulation Number
    868.6810
    Why did this record match?
    Product Code :

    BSY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This closed suction catheter system is indicated for patients with an endotracheal tube or tracheostomy tube to suction tracheobronchial secretions. This device is indicated for single patient use only. The suction catheter should be replaced after 24 hours.
    Device Description
    Not Found
    Ask a Question
    K Number
    K973199
    Device Name
    AMSINO SUCTION CATHETER
    Manufacturer
    AMSINO INTL., INC.
    Date Cleared
    1997-09-10

    (15 days)

    Product Code
    BSY
    Regulation Number
    868.6810
    Why did this record match?
    Product Code :

    BSY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Amsino Suction Catheter, tracheobronchial, is to be used to aspirate liquids or semisolids from a patient's upper airway.
    Device Description
    AMSINO® Suction Catheter
    Ask a Question
    K Number
    K961707
    Device Name
    TRACH-EZE CLOSED VENTILATION SUCTION SYSTEM
    Manufacturer
    SORENSON CRITICAL CARE
    Date Cleared
    1997-03-11

    (313 days)

    Product Code
    BSY
    Regulation Number
    868.6810
    Why did this record match?
    Product Code :

    BSY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K964369
    Device Name
    TRACH CARE SET WITH MICROBAN
    Manufacturer
    BALLARD MEDICAL PRODUCTS
    Date Cleared
    1997-02-11

    (102 days)

    Product Code
    BSY
    Regulation Number
    868.6810
    Why did this record match?
    Product Code :

    BSY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K960488
    Device Name
    NEO 2 LINE SUCTION SYSTEM
    Manufacturer
    ALCOVE MEDICAL, INC.
    Date Cleared
    1996-04-26

    (85 days)

    Product Code
    BSY
    Regulation Number
    868.6810
    Why did this record match?
    Product Code :

    BSY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K955831
    Device Name
    ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM
    Manufacturer
    SHERWOOD MEDICAL CO.
    Date Cleared
    1996-03-28

    (93 days)

    Product Code
    BSY
    Regulation Number
    868.6810
    Why did this record match?
    Product Code :

    BSY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended to be used in critical care units to aspirate secretions from patient airways who have endotracheal or tracheostomy tubes and require mechanical ventilation. The system allow for the insertion and withdrawal of a suction catheter into the artificial airway without disconnecting the patient from the ventilator circuit. The components of this system are sterile, single patient use, and disposable.
    Device Description
    The Argyle® ASPR-Care™ Closed Suction System consists of three discreet components: a dual swivel T-piece, a sheathed suction catheter, and a suction control valve. When connected together, these components form a closed system suction catheter similar in form and function to the closed system catheters available from Ballard and Concord/Portex.
    Ask a Question

    Page 1 of 2