# K254149: Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825); Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657484); Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510826); Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657485)

- Pathway: 510(k) (Traditional)
- Applicant: Sterilmed, Inc.
- Decided: Jun 29, 2026 after 189 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: 7 generations back to K921148 (1992). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240050: SOUNDSTAR™ CRYSTAL Ultrasound Catheter, Biosense Webster, Inc. (2024) Summary page 6.
- K233270: AcuNav Crystal Ultrasound Catheter, Siemens Medical Solutions USA, Inc. (2023) Summary page 6.

## Indications for use
The Reprocessed SOUNDSTAR CRYSTAL Ultrasound Catheter is indicated for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. When used with compatible CARTO 3 EP Navigation Systems, the catheter provides location information. Refer to the Biosense Webster Compatibility Matrix Insert for compatible CARTO 3 Systems as each catheter is compatible with a specific version of the CARTO 3 System and is not backward compatible with previous versions of the CARTO 3 EP Navigation System. The Reprocessed AcuNav CRYSTAL Ultrasound Catheter is intended for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

Source page: https://510kreport.com/device/K254149
Methodology: https://510kreport.com/methodology