# K201775: NuVision ICE Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Nuvera Medical, Inc.
- Decided: Mar 5, 2021 after 249 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: 1 generation back to K071234 (2007). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071234: Acunav Diagnostic Ultrasound Catheter 8F and 10F, Siemens Medical Solutions USA, Inc. (2007) Summary page 4.

## Most influential descendants
- K223766: NUVISION™ NAV Ultrasound Catheter (2023), 1 descendant of its own
- K241540: NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound Catheter (2024), 0 descendants of its own

## Indications for use
The NuVision ICE Catheter is intended 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.

Source page: https://510kreport.com/device/K201775
Methodology: https://510kreport.com/methodology