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510(k) Data Aggregation

    K Number
    K220981
    Device Name
    SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe
    Manufacturer
    Fehling Surgical Instruments, Inc.
    Date Cleared
    2023-04-20

    (381 days)

    Product Code
    DWP
    Regulation Number
    870.4475
    Why did this record match?
    Product Code :

    DWP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fehling SUPERPLAST Probes are intended to be used to enlarge or calibrate vessels during coronary artery bypass and angioplasty procedures. They are designed to locate orifices, to trace the course of abnormal vessels and to perform various maneuvers of dilation and measurement of annulus and lumen diameters.
    Device Description
    The Fehling SUPERPLAST Probes are intended to be used to enlarge or calibrate vessels during coronary artery bypass and angioplasty procedures. They are designed to locate orifices, to trace the course of abnormal vessels and to perform various maneuvers of dilation and measurement of annulus and lumen diameters. The coronary probe is available in different lengths and diameters to accommodate the needs of various surgical procedures and vessel anatomies. The probe is constructed of Titanium Alloy (TiAl6V4), Nitinol, and Titanium (Grade 2). Coronary probes are supplied non-sterile.
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    K Number
    K183438
    Device Name
    Geomed Vascular Dilators
    Manufacturer
    Geomed Medizin-Technik GmbH & Co.
    Date Cleared
    2019-09-03

    (265 days)

    Product Code
    DWP
    Regulation Number
    870.4475
    Why did this record match?
    Product Code :

    DWP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Geomed Vascular Dilators are devices used to enlarge or calibrate vessels during coronary artery bypass or angioplasty procedures. They are designed to locate orifices, to trace the course of abnormal vessels, and to perform various maneuvers of dilation and measurement of annulus and lumen diameters.
    Device Description
    Vascular Dilators are reusable stainless-steel surgical instruments that are used by qualified surgeons to enlarge or calibrate vessels. They are provided in two basic models and various sizes to accommodate individual needs, based on the anatomy of the site and the type of surgical procedure. The device is provided non-sterile for steam sterilization by the user.
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    K Number
    K163524
    Device Name
    Vessel Dilator
    Manufacturer
    Fetzer Medical GmbH & Co. KG
    Date Cleared
    2017-06-29

    (196 days)

    Product Code
    DWP
    Regulation Number
    870.4475
    Why did this record match?
    Product Code :

    DWP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fetzer Medical vessel dilators are devices used to enlarge or calibrate a vessel during cardiovascular surgery.
    Device Description
    Fetzer Medical Vessel Dilators are reusable manual surgical instruments. They are rod-like devices with a long, slender, solid shaft and a distal tip of various shapes and sizes. They are sold unsterile and can be reused (cleaned and sterilized) according the instructions for use. There are several types of dilators made from stainless steel or aluminum: - Cooley Coronary Dilators - Cooley Vessel Dilators - Garrett Vascular Dilators - Hiebert Vascular Dilators - DeBakey Vascular Dilators - Sarns-Style Dilators - Myocardial Dilators These dilators are available in a range of different length and diameters. The handle of the DeBakey Vascular Dilator, the Cooley Vessel Dilator, the Cooley Coronary Dilator, the Hiebert Vascular Dilator and the Garrett Vascular Dilator is textured with one site flat. The handles of the Sarns and Myocardial Dilators are smooth. The Myocardial Dilator has a flat distal end for holding it and the Sarns Dilator has a hollow handle at the distal end. Apart from the Hiebert Vascular Dilator and the Myocardial Dilator, the handle is connected to a thin shaft. The diameter of the shaft of the different dilator types varies. The shaft of the Cooley Coronary Dilator, the Cooley Vessel Dilator, The Garrett Vascular Dilator and the DeBakey Vascular Dilator can be thin so that the shaft is flexible. The handle of the Myocardial Dilator has no shaft while the Hiebert Vascular Dilator is double-ended; it possesses two flexible shafts, with the handle located in between the two thin shafts. The tips of all dilators have the aim to enlarge a vessel. The design of the Sarns and Myocardial Dilator is similar to an elephant's tusk. The diameter increases steadily, moving towards the handle's direction. The tips of the other Dilators are olive-shaped. The Cooley Coronary Dilator possesses no formed tip. For all dilators, the penetrating diameter corresponds to the diameter of the shaft. The Hiebert Vascular Dilators working elements are each malleable wires with an olive tip in different diameters.
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    K Number
    K130896
    Device Name
    VASCULAR PROBE, VASCULAR PROBE ES
    Manufacturer
    SYNOVIS LIFE TECHNOLOGIES, INC.
    Date Cleared
    2013-04-24

    (23 days)

    Product Code
    DWP
    Regulation Number
    870.4475
    Why did this record match?
    Product Code :

    DWP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The disposable Vascular Probe is intended to be used during coronary and peripheral vascular surgery to probe blood vessels distally and proximally for blockages, to measure the internal diameter of vessels, and to act as an intravascular retractor.
    Device Description
    The Vascular Probe is a sterile, single use, disposable device with a polyurethane coated streamline bulb on each end of a flexible polycarbonate or polycarbonate-polyurethane shaft. The bulbs are of different size on each end of the Vascular Probe. An appropriately-sized bulb is inserted either proximally or distally through the arteriotomy to probe the interior of the vessel and may be used by the surgeon to retract the vascular wall. The Vascular Probe is packaged in a double sterile barrier. The contents of the unopened, undamaged container are sterile.
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    K Number
    K100518
    Device Name
    INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054
    Manufacturer
    INSTRUMED INTERNATIONAL, INC.
    Date Cleared
    2010-08-31

    (189 days)

    Product Code
    DWP
    Regulation Number
    870.4475
    Why did this record match?
    Product Code :

    DWP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    INSTRUMED Vessel Dilators are devices used to enlarge or calibrate vessels during coronary artery bypass or angioplasty procedures. They are designed to locate orifices, to trace the course of abnormal vessels, and to perform various manoeuvres of dilation and measurement of annulus and lumen diameters.
    Device Description
    Instrumed Vessel Dilators are reusable surgical instruments. To ensure the multi-purpose use of this device, different models are available. The differences can be in length, diameter, and design of the dilators. Dilators are used to check patency of vessel in coronary artery bypass procedures, to check patency of other vessels in pheripheral vascular procedures, olive shaped tips (Garrett). The surgeon chooses the instrument based on the anatomy of the vessel and the type desired, and on the type of the surgical procedure. Instrumed Vessel Dilators are made of ASTM F 899-07 standardized Stainless Steel. The instruments are offered in non-sterile condition.
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    K Number
    K030788
    Device Name
    KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS
    Manufacturer
    GEISTER MEDIZINTECHNIK GMBH
    Date Cleared
    2003-07-12

    (122 days)

    Product Code
    DWP
    Regulation Number
    870.4475
    Why did this record match?
    Product Code :

    DWP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    GEISTER vessel dilators are devices used to enlarge or calibrate vessels during coronary artery bypass or angioplasty procedures. They are designed to locate orifices, to trace the course of abnormal vessels, and to perform various maneuvers of dilation and measurement of annulus and lumen diameters.
    Device Description
    GEISTER vessel dilators
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    K Number
    K960312
    Device Name
    RDI CARDIAC INSULATION PAD
    Manufacturer
    R D INTL.
    Date Cleared
    1996-04-19

    (88 days)

    Product Code
    DWP
    Regulation Number
    870.4475
    Why did this record match?
    Product Code :

    DWP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RDI Cardiac Insulation Pad is intended to be used during open heart surgery to insulate the myocardium from the warmer organs and tissues in the body and thus reduce undesired rewarming of the heart.
    Device Description
    The RDI Cardiac Insulation Pad consists of a pear shaped, 1/8" thick, closed cell polyethylene foam material. Attached to the foam is a 1/2" wide, 20" long, 4 mil thick, polyvinyl chloride strip referred to as a "tail".
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