# K241540: NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound Catheter

- Pathway: 510(k) (Special)
- Applicant: Biosense Webster, Inc.
- Decided: Jun 28, 2024 after 28 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: 7 generations back to K921148 (1992). 11 ancestors in all.
No later device cites it as a predicate yet.
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 5.
- K223766: NUVISION™ NAV Ultrasound Catheter, Biosense Webster, Inc. (2023) Summary page 5.

## Indications for use
The NUVISION™ Ultrasound Catheter is indicated for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures. 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/K241540
Methodology: https://510kreport.com/methodology