Definition: The Device Is Intended For Use In Dilating The Cartilaginous Portion Of The Eustachian Tube For Treating Persistent Eustachian Tube Dysfunction.
| Device Type ID | 1640 |
| Device Name | Eustachian Tube Balloon Dilation Device |
| 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 P |
| 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 Ballo |
| Target Area | Eustachian Tube |
| Regulation Description | Eustachian Tube Balloon Dilation System. |
| Regulation Medical Specialty | Ear Nose & Throat |
| Review Panel | Ear Nose & Throat |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Ear, Nose, And Throat Devices Branch (ENTB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 874.4180 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PNZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1640 |
| Device | Eustachian Tube Balloon Dilation Device |
| Product Code | PNZ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Eustachian Tube Balloon Dilation System. |
| CFR Regulation Number | 874.4180 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ACCLARENT, INC. | ||
GRANTED | 1 | |
SUBSTANTIALLY EQUIVALENT | 1 | |
ENTELLUS MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ENTELLUS MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 3 |
Unsealed Device Packaging | 1 |
| Total Device Problems | 4 |