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510(k) Data Aggregation
K Number
K093888Device Name
COOPDECH ENDOBRONCHIAL BLOCKER TUBE
Manufacturer
DAIKEN MEDICAL CO, LTD.
Date Cleared
2010-03-16
(88 days)
Product Code
CBI
Regulation Number
868.5740Why did this record match?
Applicant Name (Manufacturer) :
DAIKEN MEDICAL CO, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The COOPDECH ENDOBRONCHIAL BLOCKER TUBE is used to isolate the left or right lung of a patient for surgery, one lung ventilation or one lung anesthesia.
Patient Population: Patients requiring one lung isolation.
Environment of Use: Hospitals-OR and ICU.
Device Description
The "COOPDECH ENDOBRONCHIAL BLOCKER TUBE (MODIFIED)" consists of a bronchial blocker tube; advanced through an endotracheal catheter, and a joint connector, connecting the bronchial blocker tube to the endotracheal catheter. A cuff, incorporated at the distal tip of the tube, is inflated to block the targeted bronchus.
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K Number
K071694Device Name
COOPDECH ENDOBRONCHIAL BLOCKER TUBE, MODELS BBT-A30XXX, BBT-B30XXX
Manufacturer
DAIKEN MEDICAL CO, LTD.
Date Cleared
2008-03-20
(274 days)
Product Code
CBI
Regulation Number
868.5740Why did this record match?
Applicant Name (Manufacturer) :
DAIKEN MEDICAL CO, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The COOPDECH Endobronchial Blocker 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 "Coopdech Endobronchial Blocker Tube" consists of a bronchial blocker tube; advanced through an endotracheal catheter, and a joint connecting the bronchial blocker tube to the endotracheal catheter. A cuff, incorporated at the distal tip of the tube, is inflated to block the targeted bronchus.
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