Search Results
Found 7 results
510(k) Data Aggregation
K Number
K200190Device Name
ScalpelCric
Manufacturer
VBM Medizintechnik GmbH
Date Cleared
2020-10-30
(277 days)
Product Code
BWC, JOH, OGP, PRI
Regulation Number
868.5090Why 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
K173912Device 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
868.5800Why 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
K082528Device 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
870.1875Why 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
K083702Device Name
TRACH-ASSIST
Manufacturer
MERGENET MEDICAL
Date Cleared
2009-03-05
(80 days)
Product Code
BZA
Regulation Number
868.5810Why 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
K013865Device Name
TIP DEFLRCTING ENDOBRONCHIAL BLOCKER
Manufacturer
COOK, INC.
Date Cleared
2002-04-22
(152 days)
Product Code
CBI
Regulation Number
868.5740Why 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
K970365Device Name
PASSY-MUIR O2 ADAPTER; PMA2000
Manufacturer
PASSY-MUIR, INC.
Date Cleared
1997-02-12
(12 days)
Product Code
JOH
Regulation Number
868.5800Why 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
K955564Device Name
RUSCH ULTRA TRACHEOFLEX TRACHEOSTOMY SET, CUFFED, STERILE
Manufacturer
RUSCH, INC.
Date Cleared
1996-06-28
(205 days)
Product Code
JOH
Regulation Number
868.5800Why 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