K242863
- 510(k) number
- K242863
- Device name
- Bioptimal Bipolar Pacing Catheter
- Applicant
- Bioptimal International Pte. , Ltd. SG
- Product code
- LDF — Electrode, Pacemaker, Temporary
- Decision date
- 2025-06-15
- Date received
- 2024-09-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.4 MB · U.S. public domain
Also available from FDA: K242863.pdf
Official FDA record: K242863
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.