INSPIRA AIR BALLOON DILATION SYSTEM
FDA 510(k) clearance K110218 · decided 2011-03-31
Clearance details
- K-number
- K110218
- Device name
- INSPIRA AIR BALLOON DILATION SYSTEM
- Applicant
- Acclarent, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-01-25
- Decision date
- 2011-03-31
- Days to decision
- 65 days
- Clearance type
- Special
- Product code
- KTI
- Device class
- 2
- Regulation number
- 874.4680
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Rmenlo Park, CA, US
- Third-party review
- No
- Expedited review
- No
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