# K200812: VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Philips Image Guided Therapy Corporation
- Decided: Sep 2, 2020 after 159 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: 2 generations back to K071234 (2007). 2 ancestors in all.
1 later device descends from it; 1 cites 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)
- K170263: AcuNav Diagnostic Ultrasound Catheter 8F,10F, Siemens Medical Solutions USA, Inc. (2017) Summary page 4.

## Most influential descendants
- K251103: VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D) (2025), 0 descendants of its own

## Indications for use
The VeriSight/VeriSight Pro 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. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

Source page: https://510kreport.com/device/K200812
Methodology: https://510kreport.com/methodology