# K173262: Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Health, LLC
- Decided: Mar 6, 2018 after 146 days
- Product code: OWQ (Reprocessed Intravascular Ultrasound Catheter)
- 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.
1 later device descends from it; 1 cites it directly.
0 of 6 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 5.

## Most influential descendants
- K202042: Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter (2020), 0 descendants of its own

## Indications for use
The Reprocessed 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/K173262
Methodology: https://510kreport.com/methodology