Soundstar 3D Ultrasound Catheter Model M-5723-12
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K092064 FDA 510(k)
- FDA Product Code
- OBJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1200 FDA 510(k)
- Regulation Number
- 870.1200 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Soundstar 3D Ultrasound Catheter Model M-5723-12 is an intravascular ultrasound catheter designed for real-time imaging of cardiac and vascular structures. It provides three-dimensional visualization of cardiac anatomy, physiology, and intravascular devices, enabling detailed assessment of the heart and great vessels during diagnostic and interventional procedures.
This catheter is intended for single-use in clinical settings such as electrophysiology labs and cardiac catheterization suites. It is supplied sterile and requires compatibility with the CARTO XP EP Navigation System (Version 9.7 or greater) for location tracking. The device has received FDA 510(k) clearance under the Special 510(k) Review pathway, classified as a Class II medical device under regulation number 870.1200.
Frequently asked questions
What clinical environments is the Soundstar 3D Ultrasound Catheter primarily used in, and why is it designed for single-use?
The Soundstar 3D Ultrasound Catheter (Model M-5723-12) is designed for use in specialized clinical settings like electrophysiology labs and cardiac catheterization suites. It is intended for single-use to ensure patient safety, minimize infection risks, and maintain imaging accuracy, as reuse could compromise sterility or device performance. The catheter provides real-time 3D imaging of cardiac and vascular structures, which is critical during diagnostic and interventional procedures where precision matters.
Is this catheter compatible with other imaging systems, or does it require a specific navigation system for location tracking?
The Soundstar 3D Ultrasound Catheter requires compatibility with the CARTO XP EP Navigation System (Version 9.7 or greater) for accurate location tracking. While it is designed for real-time 3D imaging of cardiac and vascular structures, its integration with this specific system ensures seamless integration with electrophysiology and catheterization workflows, enabling precise mapping and guidance during procedures.
How should the Soundstar 3D Ultrasound Catheter be stored, and is it supplied sterile?
The Soundstar 3D Ultrasound Catheter is supplied sterile and intended for single-use, meaning it should be stored in its original packaging until ready for use. Proper storage involves keeping it in a clean, dry environment away from direct sunlight or extreme temperatures to preserve its integrity and sterility until deployment in a clinical setting.
What regulatory pathway was followed for FDA clearance of this device, and what classification does it hold?
The Soundstar 3D Ultrasound Catheter received FDA 510(k) clearance under the Special 510(k) Review pathway, classified as a Class II medical device under regulation number 870.1200. This classification reflects its role as an intravascular ultrasound catheter for real-time imaging, where moderate risk is associated with its use in cardiac and vascular procedures.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Soundstar 3d Ultrasound Catheter, Model M-5723-12 (K092064) — Fda 510 ..., Soundstar 3d Ultrasound Catheter Model M-5723-12, SOUNDSTAR™ Ultrasound Catheter | J&J MedTech US
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K092064 | Class II | Active |
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Manufacturer
- Manufacturer
- Biosense Webster Inc
- FDA Applicant
- Biosense Webster, Inc.
Sources (1)
- FDA 510(k) K092064 24 fields · synced Oct 6, 2026