510(k) K242863
K242863 is an FDA 510(k) premarket notification submitted by Bioptimal International Pte. , Ltd. for the device "Bioptimal Bipolar Pacing Catheter". The FDA issued a decision of Substantially Equivalent on June 15, 2025. The device falls under product code LDF (Electrode, Pacemaker, Temporary), a Class II device regulated under 21 CFR 870.3680. Bioptimal International Pte. , Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 15, 2025
- Date Received
- September 20, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Pacemaker, Temporary
- Device Class
- Class II
- Regulation Number
- 870.3680
- Review Panel
- CV
- Submission Type