# K231621: Reprocessed ViewFlex Xtra ICE Catheter (D087031)

- Pathway: 510(k) (Special)
- Applicant: Stryker Sustainability Solutions
- Decided: Jul 25, 2023 after 53 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: 4 generations back to K101239 (2010). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182238: Reprocessed ViewFlex Xtra ICE Catheter, Stryker Sustainability Solutions (2019) Summary page 5.
- K133853: Viewflex Xtra Ice Catheter, Irvine Biomedical, Inc., A St. Jude Medical Company (2014) Summary page 5.

## 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/K231621
Methodology: https://510kreport.com/methodology