# K182238: Reprocessed ViewFlex Xtra ICE Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Sustainability Solutions
- Decided: May 8, 2019 after 261 days
- Product code: OWQ (Reprocessed Intravascular Ultrasound Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: 1 (0 Class I)
- 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
- K231621: Reprocessed ViewFlex Xtra ICE Catheter (D087031) (2023), 0 descendants of its own

## Recalls of this device
- Mar 27, 2020 · Class II · Z-2113-2020: A subset of temporary intracardiac ultrasound catheters are labeled with the incorrect expiration date. They are mislabeled as having a shelf life of two years, while the actual shelf life is one year

## 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/K182238
Methodology: https://510kreport.com/methodology