Search Filters

Search Results

Found 7 results

510(k) Data Aggregation

    K Number
    K200190
    Device Name
    ScalpelCric
    Manufacturer
    VBM Medizintechnik GmbH
    Date Cleared
    2020-10-30

    (277 days)

    Product Code
    BWC, JOH, OGP, PRI
    Regulation Number
    868.5090
    Why did this record match?
    Search-Everything :

    Matched: '868.5810'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Emergency airway access via the cricothyroid membrane. Life-threatening dyspnoea that cannot be controlled in any other way.
    Device Description
    Surgical Cricothyrotomy set for securing the airway in case of upper airway obstruction, respectively as "Ultima Ratio" if all other attempts to ventilate the patient failed. The set consists of scalpel, bougie, tube, extension tube with swivel connector, syringe and necktape.
    Ask a Question
    K Number
    K173912
    Device Name
    BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube
    Manufacturer
    Smiths Medical ASD, Inc.
    Date Cleared
    2018-05-08

    (137 days)

    Product Code
    JOH
    Regulation Number
    868.5800
    Why did this record match?
    Search-Everything :

    Matched: '868.5810'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Controlled, elective, subcricoid percutaneous insertion of a tracheostomy tube for airway management using a Seldinger guidewire dilation technique. Controlled, elective subcricoid percutaneous insertion of a tracheostomy tube for airway management using a Seldinger technique to guide the specially designed Guidewire Dilating Forceps into trachea, which are then used to dilate the trachea.
    Device Description
    The BLUperc® and BLUgriggs® Percutaneous Dilation Tracheostomy Tube Kits or Trays aid in the tracheostomy tube surgical procedure for adult patients; designed to aid adult patients requiring an artificial breathing airway due to trauma, medical condition and/or for airway maintenance. The tracheostomy tubes (kits or trays) maximum recommended period of use is 29 days. The kit or tray contains all the proprietary procedural components to support tracheostomy insertion, including the BLUselect tracheostomy tube for physician's ease during the clinical procedure flow.
    Ask a Question
    K Number
    K082528
    Device Name
    SNOR-SCOPE PLUS OR SNOR-SCOPE + ELECTRONIC STETHOSCOPE SYSTEM
    Manufacturer
    NOBLE ANESTHESIA-AIR, INC.
    Date Cleared
    2009-03-06

    (185 days)

    Product Code
    DQD
    Regulation Number
    870.1875
    Why did this record match?
    Search-Everything :

    Matched: '868.5810'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Noble Anesthesia-Air Snor-Scope Plus™ Electronic Stethoscope is intended as a diagnostic aid in patient monitoring, diagnostics, and treatment under the same conditions that would otherwise require the use of an acoustic (non-clectronic) stethoscope. In addition, the Noble Anesthesia-Air Snor-Scope Plus Electronic Stethoscope is also intended for electronically amplifying sounds of evolving obstruction of the upper airway in patients without an endotracheal tube undergoing sedation or general anesthesia care professional. It is not intended to be used for diagnosis and treatment by unlicensed, untrained, or unqualified medical persons.
    Device Description
    The Noble Anesthesia-Air Snor-Scope Plus™ Electronic Stethoscope System is a kit comprised of the following components: - Audio amplifier module and microphone - Plastic T-connector / diaphragm coupler assembly (airway adapter) - Single Plastic coupler (stethoscope adapter) - Stethoscope Head (standard mechanical acoustic) - Stethoscope (standard mechanical acoustic) - Wall charger (UL listed, medical grade) and eight (8) batteries (rechargeable) A shielded microphone and audio cable, with a 3.5mm plug, connects the microphone/coupler assembly to the amplifier module. The speaker volume may be adjusted on the audio amplifier module to allow comfortable listening levels of breathing sounds passing through the airway circuit for Anesthesia Physicians and Clinical Personnel. A standard stethoscope ear piece may also be used for private listening purposes, although it does not provide the same amplification as in electronic stethoscope mode. The Snor-Scope Plus T-connector is composed of a plastic diaphragm and connector cap which holds the diaphragm tightly in place. This T-connector serves as an attachment for either the manual stethoscope (without head) or to the electronic stethoscope microphone. The device is not sterile, is outside the surgical field, and is a single-use disposable accessory. A single plastic medical grade coupler may also be used as an interface between the Snor-Scope Plus microphone and standard stethoscope dual-diaphragm head for the same purpose that would otherwise require an acoustic (non-electronic) stethoscope. The Noble Anesthesia-Air Electronic Stethoscope provides 20 times greater signal amplitude than a standard acoustic stethoscope. The overall frequency response is 15 - 1500 Hertz. This stethoscope is a stand-alone unit, has no software, and operates using an analog audio system without introducing any signals or energy into the patient or anesthesia breathing circuit. The Amplifier Module is powered by rechargeable Nickel Cadmium Batteries which can be easily replaced. The charger consists of a medical grade UL listed wall adapter. The batteries and charger are of the overall packaged kit. The audio amplifier module controls charging which cannot be performed during use of the Noble Anesthesia-Air Snor-Scope Plus™ Electronic Stethoscope.
    Ask a Question
    K Number
    K083702
    Device Name
    TRACH-ASSIST
    Manufacturer
    MERGENET MEDICAL
    Date Cleared
    2009-03-05

    (80 days)

    Product Code
    BZA
    Regulation Number
    868.5810
    Why did this record match?
    Search-Everything :

    Matched: '868.5810'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Trach-Assist is an airway connector intended to connect between an endotracheal tube or tracheostomy tube and the ventilator circuit or closed suction system. It can assist in removal of patient secretions that may collect in ventilatory tubing.
    Device Description
    Trach-Assist is a simple connector with standard 15 mm fittings permitting connection with an endotracheal tube or tracheostomy tube and the patient wye of a breathing circuit. The Trach-Assist H has a port for insertion of a suction catheter to remove secretions while Trach-Assist-I uses Closed Suction Catheter system to remove secretions.
    Ask a Question
    K Number
    K013865
    Device Name
    TIP DEFLRCTING ENDOBRONCHIAL BLOCKER
    Manufacturer
    COOK, INC.
    Date Cleared
    2002-04-22

    (152 days)

    Product Code
    CBI
    Regulation Number
    868.5740
    Why did this record match?
    Search-Everything :

    Matched: '868.5810'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tip Deflecting Endobronchial Blocker is intended for use to differentially intubate a single lumen tube to isolate the left or right lung for procedures which require one-lung ventilation.
    Device Description
    The Tip-Deflecting Endobronchial Blocker is designed for use with a standard endotracheal tube and a small diameter fiberoptic bronchoscope to be placed inside a single lumen tube to provide one lung ventilation. It uses a flexible soft tip that can be deflected to more than 90 degrees and easily placed into the desired bronchus to be blocked. The device measures 9.0 French in outside diameter and fits coaxially with a 7.0 mm or larger endotracheal tube. The proximal end of the catheter is made up of a pilot balloon assembly. This balloon assembly has one litting to inflate the distal balloon and maintains inflation until it is deflated. Facilitation of this device will include an Arndt Multiport Airway Adapter (Class I, Exempt, §868.5810), a CPAP Adapter (Class I, Exempt, §868.5810), and a syringe (vendor supplied).
    Ask a Question
    K Number
    K970365
    Device Name
    PASSY-MUIR O2 ADAPTER; PMA2000
    Manufacturer
    PASSY-MUIR, INC.
    Date Cleared
    1997-02-12

    (12 days)

    Product Code
    JOH
    Regulation Number
    868.5800
    Why did this record match?
    Search-Everything :

    Matched: '868.5810'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The P-M O2 Adapter is designed for use with the companion PMV 2000 (clear) and PMV 2001 (purple) Low Profile Tracheostomy and Ventilator Speaking Valves. The P-M O2 Adapter allows for improved mobility of those patients requiring a tracheostomy tube, speaking valve, and low flow supplemental oxygen.
    Device Description
    The Passy-Muir O2 Adapter is a one-piece, injection-molded plastic device designed to attach to the outer surface of either one of the Passy-Muir Low-Profile Tracheostomy and Ventilator Speaking Valves (PMV 2000 or PMV 2001) and provide a means for connecting a supplemental oxygen supply tube
    Ask a Question
    K Number
    K955564
    Device Name
    RUSCH ULTRA TRACHEOFLEX TRACHEOSTOMY SET, CUFFED, STERILE
    Manufacturer
    RUSCH, INC.
    Date Cleared
    1996-06-28

    (205 days)

    Product Code
    JOH
    Regulation Number
    868.5800
    Why did this record match?
    Search-Everything :

    Matched: '868.5810'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Rusch Ultra Tracheoflex Tracheostomy Set-Cuffed is a tracheostomy tube with accessories, intended for intubation through a surgical incision into the trachea, for the purpose of providing a patent airway.
    Device Description
    The Ultra Tracheoflex Tracheostomy Set-Cuffed is a sterile, disposable, single use cuffed tracheostomy tube with a fixed flange. The set includes a radiopaque tube, a tube obturator, a cough cap, a 15 mm airway connector, exchangeable inner cannulas, and a neck band. The inner cannula will be also available as a separate item.
    Ask a Question

    Page 1 of 1