# K163560: Reprocessed AcuNav Diagnostic Ultrasound Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Health, LLC
- Decided: Jul 12, 2017 after 205 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 K071234 (2007). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153090: Reprocessed Diagnostic Ultrasound Catheter, Innovative Health, LLC (2016) Summary page 5.
- K071234: Acunav Diagnostic Ultrasound Catheter 8F and 10F, Siemens Medical Solutions USA, Inc. (2007) Summary page 5.

## 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/K163560
Methodology: https://510kreport.com/methodology