Class Class II
Bioptimal Bipolar Pacing Catheter (K242863)
Description
Bioptimal Bipolar Pacing Catheter by Bioptimal International Pte. , Ltd., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242863
Clearance Date2025-06-15
Clearance TypeTraditional
Product CodeLDF
Regulation Number870.3680
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242863
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Bioptimal Bipolar Pacing Catheter (K242863) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K161873 | Pacel Flow Directed Pacing Catheter | St Jude Medical | 2016 |
Trace the full predicate network for K242863
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.