Class Class II
NUVISION™ NAV Ultrasound Catheter (K223766)
Description
NUVISION™ NAV Ultrasound Catheter by Biosense Webster, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223766
Clearance Date2023-02-16
Clearance TypeTraditional
Product CodeOBJ
Regulation Number870.1200
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223766
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. NUVISION™ NAV Ultrasound Catheter (K223766) cites 2 predicate devices and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K201775 | NuVision ICE Catheter | Nuvera Medical, Inc. | 2021 |
| K112050 | SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER | Biosense Webster, Inc. | 2011 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241540 | NUVISION Ultrasound Catheter; NUVISION NAV Ultrasound Cat... | Biosense Webster, Inc. | 2024 |
| K223832 | Vivid S60N, Vivid S70N | Ge Medical System Ultrasound and Pr... | 2023 |
Trace the full predicate network for K223766
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.