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510(k) Data Aggregation
K Number
K060094Device Name
ARCADIA MEDICAL SILICONE WIRE REINFORCED ENDOTRACHEAL TUBES
Manufacturer
ARCADIA MEDICAL CORPORATION
Date Cleared
2006-05-08
(116 days)
Product Code
BTR
Regulation Number
868.5730Why did this record match?
Applicant Name (Manufacturer) :
ARCADIA MEDICAL CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Endotracheal Tubes are indicated for use in providing airway management by oral intubation of the trachea during anesthesia and during ventilator support of respiration. Wire Reinforced Endotracheal Tubes are indicated for use in procedures requiring flexing of the neck or movement of the patient (lateral or prone position).
Device Description
Arcadia Medical® Silicone Wire Reinforced Endotracheal Tubes are available in Cuffless or Air Cuff styles. All tubes consist of a radiopaque biocompatible wire reinforced silicone shaft and have a standard 15mm connector, depth marks in centimeters and two ring marks behind the cuff for reference in determining the position of the cuff or distal tip in the trachea.
Air Cuff Endotracheal Tubes have a radiopaque hooded tip to ease insertion through the vocal cords. Air Cuff Tubes also have an Above the Cuff Access Port (ACAP)® for removing secretions above the cuff to help prevent aspiration.
Air Cuff Endotracheal Tubes have an inflatable air cuff to seal the trachea. When properly inflated, the air cuff conforms to the shape of the trachea providing an effective seal. The tube has an inflation line with a luer valve and blue pilot balloon to indicate cuff inflation.
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K Number
K031553Device Name
SILICONE FOAM CUFF TRACHEOSTOMY TUBES, SILICONE CUFFLESS NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES
Manufacturer
ARCADIA MEDICAL CORPORATION
Date Cleared
2003-11-18
(183 days)
Product Code
BTO
Regulation Number
868.5800Why did this record match?
Applicant Name (Manufacturer) :
ARCADIA MEDICAL CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Tracheostomy tubes are intended for use in providing direct tracheal access for airway management.
Device Description
The document describes several types of Silicone Tracheostomy Tubes: Silicone Foam Cuff Tracheostomy Tubes, Silicone Cuffless Neonatal and Pediatric Tracheostomy Tubes, Silicone Cuffless Adult Tracheostomy Tubes, and Silicone Air Cuff and Air Cuff Adjustable Neck Flange Tracheostomy Tubes. These devices are made of silicone, are radiopaque, and are white or clear in color. They include a 15mm connector and an obturator. The packaging is a PETG Tray with Tyvek Lid or a Tyvek Pouch, and they are packaged with accessories including Twill Tape and a Disconnect Wedge. Sterilization is by ETO. Labels contain product information such as name, style, size, part number, ID, OD, length, lot number, manufacturer's name, quantity, sterilization method, and expiration date. The devices comply with ASTM F 1666-95 and ASTM F 1627-95 standards.
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