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510(k) Data Aggregation
K Number
K200968Device Name
ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R
Manufacturer
INSUNG MEDICAL CO., LTD.
Date Cleared
2020-12-28
(262 days)
Product Code
CBI
Regulation Number
868.5740Why did this record match?
Applicant Name (Manufacturer) :
INSUNG MEDICAL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended for use in thoracic surgery, bronchospirometry, administration of Endobronchial anesthesia and other uses commonly requiring Endobronchial intubation. The Endobronchial tube is indicated for main stem bronchus intubation and allows for selective inflation or deflation of either lung.
Device Description
ANKOR Endobronchial tube is consisted with double lumen tube with the body including 3 cuff (Bronchus Cuff, Trachea Cuff and ANKOR Cuff) / 2 cuff (Bronchus Cuff and Trachea Cuff), the stylet and elbow connector in order to separate connector for isolating and ventilating one lung during surgical procedures. The different point, between ABC Model and HBC Model, is whether ANKOR Cuff is consisted. ANKOR Cuff, which is a part of the ABC Model only, takes to check correct insertion of the catheter. When user is lack of the experience or is not confidence with operation, ABC Model is intended to use. When the suction is necessary, this device can be possible to be assemble with suction catheter which is 10Fr or 12Fr with PVC (Listing Number: D422226) and this device is packaged with these suction catheter (Listing Number: D422226). The device is made of silicone as a main material and is available in 33Fr to 39Fr depending on the patients who is requiring one-lung isolation under OR and ICU including Non-MR Environment only.
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