Relieva Tract Balloon Dilation System
FDA 510(k) clearance K183090 · decided 2019-04-19
Clearance details
- K-number
- K183090
- Device name
- Relieva Tract Balloon Dilation System
- Applicant
- Acclarent, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-11-06
- Decision date
- 2019-04-19
- Days to decision
- 164 days
- Clearance type
- Traditional
- Product code
- QGK
- Device class
- 1
- Regulation number
- 874.4420
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Irvin, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.