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U.S. Department of Health and Human Services

Product Classification

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Device eustachian tube balloon dilation device
Regulation Description Eustachian tube balloon dilation system.
Definition The device is intended for use in dilating the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction.
Physical State A Eustachian tube balloon dilation device consists of a catheter with an inflatable, plastic balloon, which is located at the flexible, distal end. The catheter shaft has a dual lumen to enable inflation of the balloon and has a soft, balled tip to prevent advancement into the bony isthmus of the Eustachian tube. The catheter materials are primarily plastic and stainless steel and the balloon is also plastic. The catheter joints are bonded using adhesives.
Technical Method The balloon catheter is loaded through a guide catheter through the nose to the Eustachian tube. The balloon is manually advanced and inserted into the cartilaginous Eustachian tube and inflated to a desired pressure and specified duration. The balloon is then deflated and removed from the nose.
Target Area Eustachian tube
Regulation Medical Specialty Ear Nose & Throat
Review Panel Ear Nose & Throat
Product CodePNZ
Premarket Review Division of Dental and ENT Devices (DHT1B)
Division of Dental and ENT Devices (DHT1B)
Submission Type 510(k)
Regulation Number 874.4180
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible