Search Filters

Search Results

Found 7 results

510(k) Data Aggregation

    K Number
    K140321
    Device Name
    INITARY BETTER BLADDER-PEDIATRIC
    Manufacturer
    CIRCULATORY TECHNOLOGY, INC.
    Date Cleared
    2014-04-17

    (58 days)

    Product Code
    DTN, DAT
    Regulation Number
    870.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    CIRCULATORY TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Better-Bladder™ is a device that isolates from blood contact when measurements of blood pressure in extracorporeal circuits are made during term procedures. The pressure signal can be used to control pump speed. It is also used as an inline reservoir to provide compliance in the circuit during short and long term procedures.
    Device Description
    The Better-Bladder™ (BB) is a length of standard perfusion tubing, a portion of which has been processed to form a sausage shaped balloon with a thin wall that is then sealed within a clear, rigid housing. This device can be used as an inline blood reservoir during extracorporeal circulation. It can also be used to monitor the blood pressure noninvasively: because the pressure of blood flowing inside the tubing is transmitted across the thin wall to the housing chamber, this pressure can be monitored via a pressure monitoring line to a pressure sensor. The BB thereby serves as a pressure transducer protector, isolating the blood from the pressure sensor and allowing noninvasive pressure measurements, which in turn can be used as input signals to control the pump speed.
    Ask a Question
    K Number
    K012942
    Device Name
    THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, CATALOG NUMBER VACBOX1500
    Manufacturer
    CIRCULATORY TECHNOLOGY, INC.
    Date Cleared
    2001-11-05

    (66 days)

    Product Code
    DTN
    Regulation Number
    870.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    CIRCULATORY TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The V-Bag™ with the Vac-Box™ are designed for use in an extracorporeal circuit to provide a volume reservoir, compliance, and assist in removing air during the vacuum assisted venous drainage operating mode.
    Device Description
    Not Found
    Ask a Question
    K Number
    K001822
    Device Name
    THE V-BAG
    Manufacturer
    CIRCULATORY TECHNOLOGY, INC.
    Date Cleared
    2000-07-07

    (21 days)

    Product Code
    DTN
    Regulation Number
    870.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    CIRCULATORY TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K981284
    Device Name
    BETTER-BLADDER (BB)
    Manufacturer
    CIRCULATORY TECHNOLOGY, INC.
    Date Cleared
    1998-08-12

    (126 days)

    Product Code
    DTN
    Regulation Number
    870.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    CIRCULATORY TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Better-Bladder™ is a device that isolates pressure transducers from blood contact when measurements of blood pressure in extracorporeal circuits are made during short and long term procedures. The pressure signal can be used to control pump speed. It is also used as an inline reservoir to provide compliance in the circuit during short and long term procedures.
    Device Description
    The BB consists of a unitary length of tubing, a section of which has been processed to form an enlarged diameter with a thinner wall. The enlarged section is very responsive to pressure differences across its thin wall. Because the entire device is made from a single length of smooth perfusion tubing, there are no connections between the thinker wall tubing portions. This unique design eliminates both physical and material (chemical) discontinuities. The thin walled section in its housing can withstand over 1500 mmHg (three times the maximum pressure expected under worst-case clinical conditions). The BB does not incorporate vent tubes for air aspiration or drug infusion. These can be added by placing a perfusion connector with a dual Luer fitting (e.g. Avecor Model # DL1414) at the inlet to the BB, see Fig. 7b.
    Ask a Question
    K Number
    K964205
    Device Name
    BETTER-TUBING
    Manufacturer
    CIRCULATORY TECHNOLOGY, INC.
    Date Cleared
    1998-04-08

    (537 days)

    Product Code
    DWF
    Regulation Number
    870.4210
    Why did this record match?
    Applicant Name (Manufacturer) :

    CIRCULATORY TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Better-Tubing™ is designed for use as a blood compatible conduit for pumping blood in a roller pump during cardiopulmonary bypass or other extracorporeal applications of up to 6 hours.
    Device Description
    The Better-Tubing™ (BT) is a 6 ft. length of ¼' ID tubing for use in an extracorporeal cardiopulmonary bypass circuit. It is biocompatible, has high tensile strength, and has many advantages over standard tubing made from polyvinyl chloride (PVC).
    Ask a Question
    K Number
    K964337
    Device Name
    BETTER-BLADDER (BB)
    Manufacturer
    CIRCULATORY TECHNOLOGY, INC.
    Date Cleared
    1997-05-23

    (204 days)

    Product Code
    FIB
    Regulation Number
    876.5820
    Why did this record match?
    Applicant Name (Manufacturer) :

    CIRCULATORY TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Better-Bladder™ is a device that isolates pressure transducers from blood contact when measurements of blood pressure in extracorporeal circuits are made. The noninvasive pressure obtained. with the BB can be used to control pump speed. It is also used as an inline reservoir to provide compliance in the circuit during routine bypass procedures.
    Device Description
    The Better-Bladder™ is a device that isolates pressure transducers from blood contact when measurements of blood pressure in extracorporeal circuits are made. The noninvasive pressure obtained. with the BB can be used to control pump speed. It is also used as an inline reservoir to provide compliance in the circuit during routine bypass procedures.
    Ask a Question
    K Number
    K961594
    Device Name
    BETTER-VENTER
    Manufacturer
    CIRCULATORY TECHNOLOGY, INC.
    Date Cleared
    1996-09-05

    (134 days)

    Product Code
    DWF
    Regulation Number
    870.4210
    Why did this record match?
    Applicant Name (Manufacturer) :

    CIRCULATORY TECHNOLOGY, INC.

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

    Page 1 of 1