Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K042449
    Device Name
    DOLPHIN INFLATION DEVICE
    Manufacturer
    SEDAT S.A.
    Date Cleared
    2005-04-18

    (221 days)

    Product Code
    MAV, DTL, REG
    Regulation Number
    870.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    SEDAT S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DOLPHIN Inflation Device is intended for use during cardiovascular procedures to create, maintain and monitor pressure in the balloon catheter.
    Device Description
    DOLPHIN is a single-use, sterile, and ergonomically designed inflation device used in cardiovascular procedures to pressurize (inflate) and depressurize (deflate) balloon catheters. The device itself consists of two components - the inflation device and large volume syringe (30 cc). The manually operation of the DOLPHIN is achieved by the manipulation of a large handle to drive a piston housed within the body of the device. Careful and controlled inflation is achieved by rotating the handle clockwise. During inflation a unique cam locking mechanism maintains pressure even if the user lets go of the device. Instantaneous deflation, regardless of balloon size, is made possible by the release of the dual locks located on device as well as a large, 30 cc syringe that is sold with each Dolphin Inflation Device. All the while during inflation or deflation pressure is displayed and can be monitored on a large analog gauge mounted on top of the device.
    Ask a Question
    K Number
    K040498
    Device Name
    MYSHELL
    Manufacturer
    SEDAT S.A.
    Date Cleared
    2004-07-02

    (127 days)

    Product Code
    DTL
    Regulation Number
    870.4290
    Why did this record match?
    Applicant Name (Manufacturer) :

    SEDAT S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MYSHELL is indicated for maintaining a seal around diagnostic/interventional devices with an outside diameter <9F (<.098") during interventional procedures. The 3-way stopcock, Alligatork and guidewire introducer are accessories used in conjunction with MYSHELL to facilitate interventional procedures. MYSHELL and its accessories are indicated for assisting, manipulating and maintaining a seal around diagnostic/interventional devices with an outside diameter <9F (.098") used in interventional procedures.
    Device Description
    MYSHELL is an ergonomically designed y-connector/hemostatic valve that accepts materials up to 9F in size (<.098"). The watertight double hemostatic silicone valve is manipulated by a valve opening mechanism on the external body of MYSHELL. The opening mechanism allows for precise control of the internal valve: press gradually on the mechanism for a controlled opening, push the mechanism entirely in for a complete and locked opening, or completely close the valve by depressing on the mechanism in its locked position.
    Ask a Question

    Page 1 of 1