Class Class II
CARTO™ 3 EP Navigation System V8.1 (K252302)
Description
CARTO™ 3 EP Navigation System V8.1 by Biosense Webster, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK252302
Clearance Date2025-08-22
Clearance TypeSpecial
Product CodeDQK
Regulation Number870.1425
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K252302
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. CARTO™ 3 EP Navigation System V8.1 (K252302) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231207 | CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG... | Biosense Webster, Inc. | 2023 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K252972 | CARTO 3 EP Navigation System V8.4 | Biosense Webster, Inc. | 2026 |
Trace the full predicate network for K252302
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.