# K153090: Reprocessed Diagnostic Ultrasound Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Health, LLC
- Decided: Mar 10, 2016 after 136 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: 1 generation back to K071234 (2007). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071234: Acunav Diagnostic Ultrasound Catheter 8F and 10F, Siemens Medical Solutions USA, Inc. (2007) Summary page 5.

## Most influential descendants
- K163560: Reprocessed AcuNav Diagnostic Ultrasound Catheter (2017), 0 descendants of its own

## Indications for use
The Reprocessed Acunav Diagnostic Ultrasound Catheter is intended for intracardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult patients. The reprocessed device is not indicated for use with pediatric patients.

Source page: https://510kreport.com/device/K153090
Methodology: https://510kreport.com/methodology