Bioptimal Bipolar Pacing Catheter
FDA 510(k) clearance K242863 · decided 2025-06-15
Clearance details
- K-number
- K242863
- Device name
- Bioptimal Bipolar Pacing Catheter
- Applicant
- Bioptimal International Pte. , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2024-09-20
- Decision date
- 2025-06-15
- Days to decision
- 268 days
- Clearance type
- Traditional
- Product code
- LDF
- Device class
- 2
- Regulation number
- 870.3680
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Singapore, SG
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.