Class Class II
OPTRELL™ Mapping Catheter with TRUEref™ Technology (K230253)
Description
OPTRELL™ Mapping Catheter with TRUEref™ Technology by Biosense Webster, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230253
Clearance Date2023-03-02
Clearance TypeSpecial
Product CodeMTD
Regulation Number870.1220
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230253
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. OPTRELL™ Mapping Catheter with TRUEref™ Technology (K230253) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K211438 | OPTRELL Mapping Catheter with TRUEref Technology | Biosense Webster, Inc. | 2022 |
Trace the full predicate network for K230253
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.