# K232130: Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Instrument Services and Savings, Inc.
- Decided: Dec 15, 2023 after 151 days
- Product code: OWQ (Reprocessed Intravascular Ultrasound Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: 2 (2 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.
No later device cites it as a predicate yet.
1 of 5 devices in its family (counting itself) has 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 6.

## Recalls of this device
- Dec 22, 2025 · Class I · Z-1323-2026: These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous react
- Jul 31, 2025 · Class I · Z-2613-2025: Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is

## Indications for use
The Medline ReNewal 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/K232130
Methodology: https://510kreport.com/methodology