Clearance Summary
KardiaPSI Balloon Catheter received FDA 510(k) clearance under submission number K253855, sponsored by Intervention Tech, Inc. ; dba Corvention. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2026-05-06.
- Submission: K253855
- Applicant / Sponsor: Intervention Tech, Inc. ; dba Corvention
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1255
- Decision date: 2026-05-06
Classification & Regulation
This clearance is catalogued under FDA product code OZT and 21 CFR 870.1255, within the Cardiovascular review panel as a Class II device.