Clearance Summary
Bioptimal Bipolar Pacing Catheter received FDA 510(k) clearance under submission number K242863, sponsored by Bioptimal International Pte. , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2025-06-15.
- Submission: K242863
- Applicant / Sponsor: Bioptimal International Pte. , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3680
- Decision date: 2025-06-15
Classification & Regulation
This clearance is catalogued under FDA product code LDF and 21 CFR 870.3680, within the Cardiovascular review panel as a Class II device.