CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4 (K223733)
Description
CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4 by Biosense Webster, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223733
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 with CARTOSOUND™ 4D Version 7.4 (K223733) cites 1 predicate device and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K213264 | CARTO 3 EP Navigation System Version 7.2 | Biosense Webster, Inc. | 2021 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231207 | CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG... | Biosense Webster, Inc. | 2023 |
| K223832 | Vivid S60N, Vivid S70N | Ge Medical System Ultrasound and Pr... | 2023 |
Trace the full predicate network for K223733
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.