# K223766: NUVISION™ NAV Ultrasound Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Biosense Webster, Inc.
- Decided: Feb 16, 2023 after 63 days
- Product code: OBJ (Catheter, Ultrasound, Intravascular)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K921148 (1992). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201775: NuVision ICE Catheter, Nuvera Medical, Inc. (2021) Summary page 4.
- K112050: Soundstar Eco Diagnostic Ultrasound Catheter, Biosense Webster, Inc. (2011) Summary page 4.

## Most influential descendants
- K241540: NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound Catheter (2024), 0 descendants of its own

## Indications for use
The NUVISION™ NAV Ultrasound Catheter and related accessory devices are indicated for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. When used with the compatible CARTO™ 3 EP Navigation System, the catheter provides location information. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

Source page: https://510kreport.com/device/K223766
Methodology: https://510kreport.com/methodology