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510(k) Data Aggregation
K Number
K150280Device Name
PulmoVia Working Channel
Manufacturer
Date Cleared
2015-06-11
(126 days)
Regulation Number
874.4680Why did this record match?
Applicant Name (Manufacturer) :
SANOVAS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Pulmo Via Working Channel is intended to be used as an access channel through which a bronchoscope and other endoscopic tools may be introduced to treat targeted tissue of the airways. The Pulmo Via Working Chamel can also provide means for bronchoalveolar lavage. The PulmoVia Working Channel is indicated for adult patients.
Device Description
The PulmoVia Working Channel is a single-use disposable, terminally-sterilized device for transtracheal access to bronchi of the lungs, and consists of a hollow tube with an angled flexible tip to assist in anatomical navigation. A radiopaque marker is located 4 mm from the distal tip to aid in localization under fluoroscopy/CT. Printed markings are positioned at 370 mm from the distal tip, and every 50 mm proximally from that point. The distal tip of the device has a pliable leading edge. The device also contains a disposable Tuohy-Borst adaptor to allow use of third-party devices such as ultrathin bronchoscopes. The full assembly will be packaged in a polyethylene and Tyvek pouch, sterilized via ethylene oxide (EO).
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