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510(k) Data Aggregation

    K Number
    K243861
    Device Name
    butterflyBVM
    Manufacturer
    Compact Medical, Inc.
    Date Cleared
    2025-04-25

    (130 days)

    Product Code
    BTM
    Regulation Number
    868.5915
    Why did this record match?
    Applicant Name (Manufacturer) :

    Compact Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The butterflyBVM™ when used in transport and non-clinical emergency settings (e.g., EMS, non-hospital) is a single-use resuscitator that may be manipulated to provide pulmonary resuscitation of patients including adults, adolescents, children, infants, and neonates. The butterflyBVM™ when used in professional healthcare facilities (e.g., hospitals) is a single-use resuscitator that may be manipulated to provide pulmonary resuscitation of patients including adults, adolescents, children, and infants.
    Device Description
    The butterflyBVM™ is a three-in-one bag-valve-mask capable of resuscitating adults, adolescents, children, infants, and neonates. The maximum tidal volumes (Vt) delivered by the butterflyBVM™ can be set via the tidal volume dial, as needed, to ranges that are generally appropriate for the size of patient receiving care. The butterflyBVM™ also has an adjustable peak inspiratory pressure (PIP) dial to help prevent barotrauma. The tidal volume and PIP are selected by aligning the dials to the Vt/PIP indicator. Patient-facing accessories such as masks, laryngeal mask airways, endotracheal tubes, end-tidal CO2 samplers, and the like can be connected to the patient connection port. Exhalation accessories such as bio filters and PEEP valves can be connected to the exhalation port. Supplemental oxygen can be added via the oxygen inlet port. The device is operated by manually squeezing the side arms together with either one or two hands. A cover is provided over the PIP dial to provide instruction to the user via images and words to first set the tidal volume for the procedure based on the assessment of the patient.
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    K Number
    K990693
    Device Name
    FLEXNEEDLE PLUS
    Manufacturer
    ACT MEDICAL, INC.
    Date Cleared
    1999-05-14

    (72 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACT MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FlexNeedle ® Plus is intended for use in the short term or intermittent transcutaneous cannulation of implanted venous access ports and is designed with the purpose of reducing accidental needlesticks.
    Device Description
    The FlexNeedle Plus is comprised of a flexible catheter, a body with elastomeric septum and side port; sidearm tubing with a luer infusion fitting, cap and pinch clamp; and an insertion stylet with a safety housing for capturing the sharp upon removal.
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    K Number
    K953967
    Device Name
    ENDOSCOPIC CATHETER
    Manufacturer
    ACT MEDICAL, INC.
    Date Cleared
    1996-01-22

    (153 days)

    Product Code
    ODD
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACT MEDICAL, INC.

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