Clearance Summary
Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System received FDA 510(k) clearance under submission number K152329, sponsored by C2 Therapeutics, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2016-04-13.
- Submission: K152329
- Applicant / Sponsor: C2 Therapeutics, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4350
- Decision date: 2016-04-13
Classification & Regulation
This clearance is catalogued under FDA product code GEH and 21 CFR 878.4350, within the General, Plastic Surgery review panel as a Class II device.