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510(k) Data Aggregation
K Number
K092886Device Name
WELL LEAD ENDOBRONCHIAL TUBES
Manufacturer
WELL LEAD INSTRUMENTS
Date Cleared
2010-03-11
(171 days)
Product Code
CBI
Regulation Number
868.5740Why did this record match?
Applicant Name (Manufacturer) :
WELL LEAD INSTRUMENTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Well Lead Endobronchial Tube is used to isolate the left or right lung of a patient for surgery, one lung ventilation or one lung anesthesia.
Device Description
The Well Lead Endobronchial Tube is made of Polyvinylchloride and is available in sizes 28fr to 41fr. They are designated as double lumen tube with 2 cuffs and separate 15mm connectors for isolating and ventilating one lung during surgical procedures. The tubes contain an x-ray opaque line that runs through the tube making them detectable by x-ray.
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