# K251231: ViewFlex™ X ICE Catheter, Sensor Enabled™

- Pathway: 510(k) (Special)
- Applicant: Abbott Medical
- Decided: May 20, 2025 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: 4 generations back to K101239 (2010). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223077: ViewFlex Xtra ICE Catheter, Irvine Biomedical, A St. Jude Medical Company (2022) Summary page 5.

## Indications for use
The ViewFlex ™ X ICE Catheter Sensor Enabled ™ is indicated for use in adult and adolescent pediatric patients for intra-cardiac and intra-luminal visualization of cardiac and great vessels anatomy and physiology, as well as visualization of other devices in the heart. When used with a compatible three-dimensional mapping system, the catheter provides location information.

Source page: https://510kreport.com/device/K251231
Methodology: https://510kreport.com/methodology