# K121913: Reprocessed Ultrasound Intracardiac Echo Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Sustainability Solutions, Inc.
- Decided: Dec 20, 2012 after 171 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: 2 generations back to K921750 (1992). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980851: Galaxy Intravascular Ultrasound System, Model I5028, Boston Scientific Corp (1998) Summary page 1.

## Indications for use
The Reprocessed Ultra IntraCardiac Echo Diagnostic Ultrasound rounded tip catheter is indicated for enhanced ultrasonic visualization of intracardiac structures.

Source page: https://510kreport.com/device/K121913
Methodology: https://510kreport.com/methodology