Clearance Summary
CIANNA S1, SINGLE LUMEN BALLOON APPLICATOR KIT received FDA 510(k) clearance under submission number K103215, sponsored by Cianna Medical. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2010-11-15.
- Submission: K103215
- Applicant / Sponsor: Cianna Medical
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5700
- Decision date: 2010-11-15
Classification & Regulation
This clearance is catalogued under FDA product code JAQ and 21 CFR 892.5700, within the Radiology review panel as a Class II device.