# K133853: Viewflex Xtra Ice Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Irvine Biomedical, Inc., A St. Jude Medical Company
- Decided: May 19, 2014 after 151 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 K101239 (2010). 3 ancestors in all.
14 later devices descend from it; 8 cite it directly.
1 of 18 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121381: Viewflex Xtra Ice Catheter, St Jude Medical (2012) Summary page 1.
- K071234: Acunav Diagnostic Ultrasound Catheter 8F and 10F, Siemens Medical Solutions USA, Inc. (2007) Summary page 1.

## Most influential descendants
- K222217: ViewFlex Xtra Reprocessed ICE Catheter (2022), 5 descendants of its own
- K230934: ViewFlex™ Eco Reprocessed ICE Catheter (2023), 4 descendants of its own
- K223077: ViewFlex Xtra ICE Catheter (2022), 4 descendants of its own
- K231588: ViewFlex™ Eco Reprocessed ICE Catheter (2023), 3 descendants of its own
- 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

## 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/K133853
Methodology: https://510kreport.com/methodology