# K223077: ViewFlex Xtra ICE Catheter

- Pathway: 510(k) (Special)
- Applicant: Irvine Biomedical, A St. Jude Medical Company
- Decided: Dec 7, 2022 after 68 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: 3 generations back to K101239 (2010). 4 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133853: Viewflex Xtra Ice Catheter, Irvine Biomedical, Inc., A St. Jude Medical Company (2014) Summary page 4.

## Most influential descendants
- K251211: ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid Mapping Catheter, Sensor Enabled™; Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™; Agilis™ NxT Steerable Introducer; Agilis™ NxT Steerable Introducer Dual-Reach™ (2025), 2 descendants of its own
- K250305: Reprocessed Agilis NxT Steerable Introducer (2026), 0 descendants of its own
- K250314: Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer (2025), 0 descendants of its own
- K251231: ViewFlex™ X ICE Catheter, Sensor Enabled™ (2025), 0 descendants of its own

## Indications for use
The ViewFlex™ Xtra ICE Catheter is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures, blood flow and other devices within the heart.

Source page: https://510kreport.com/device/K223077
Methodology: https://510kreport.com/methodology