# K121381: Viewflex Xtra Ice Catheter

- Pathway: 510(k) (Special)
- Applicant: St Jude Medical
- Decided: Jun 7, 2012 after 30 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- 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 K101239 (2010). 1 ancestor in all.
15 later devices descend from it; 1 cites it directly.
1 of 17 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101239: Viewflex Plus Ice Catheter, St Jude Medical (2010) Summary page 1.

## Most influential descendants
- K133853: Viewflex Xtra Ice Catheter (2014), 14 descendants of its own
- 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

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

Source page: https://510kreport.com/device/K121381
Methodology: https://510kreport.com/methodology