Clearance Summary
Elation Pulmonary Balloon Dilation received FDA 510(k) clearance under submission number K161392, sponsored by Merit Medical Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2016-09-01.
- Submission: K161392
- Applicant / Sponsor: Merit Medical Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4680
- Decision date: 2016-09-01
Classification & Regulation
This clearance is catalogued under FDA product code KTI and 21 CFR 874.4680, within the Ear, Nose, Throat review panel as a Class II device.