Soundstar 3D Ultrasound Catheter Model M-5723-12
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K101138 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 intracardiac and intraluminal imaging. It provides real-time visualization of cardiac and great vessel anatomy, physiology, and the positioning of other intracardiac devices. The device integrates ultrasound imaging with electroanatomical mapping systems to enhance procedural guidance during cardiac interventions.
This catheter is intended for single-use in clinical settings such as cardiac catheterization labs. It is supplied sterile and requires compatibility with the CARTO XP EP Navigation System (Version 9.7 or greater) for location tracking and mapping. The device is classified as Class II under FDA regulations and holds a 510(k) clearance for cardiovascular use. No MRI safety information is specified, and storage conditions are not detailed in the provided data.
Frequently asked questions
What is the Soundstar 3D Ultrasound Catheter Model M-5723-12 used for?
The Soundstar 3D Ultrasound Catheter Model M-5723-12 is designed for intracardiac and intraluminal imaging. It provides real-time visualization of cardiac and great vessel anatomy, physiology, and the positioning of intracardiac devices. This helps clinicians guide procedures more effectively during cardiac interventions by integrating ultrasound imaging with electroanatomical mapping systems.
How is the Soundstar 3D Ultrasound Catheter Model M-5723-12 supplied and intended for use?
The catheter is supplied sterile and intended for single-use in clinical settings such as cardiac catheterization labs. It is specifically designed to work with the CARTO XP EP Navigation System (Version 9.7 or greater) for location tracking and mapping, ensuring compatibility with this system is essential for its functionality.
Is the Soundstar 3D Ultrasound Catheter Model M-5723-12 reusable or single-use?
The Soundstar 3D Ultrasound Catheter Model M-5723-12 is explicitly intended for single-use only. This design choice helps ensure patient safety and sterility, as single-use devices are not intended to be reused or reprocessed.
What system compatibility does the Soundstar 3D Ultrasound Catheter Model M-5723-12 require?
The catheter requires compatibility with the CARTO XP EP Navigation System, specifically Version 9.7 or greater. This system is used for location tracking and mapping, which enhances the procedural guidance capabilities of the ultrasound catheter during cardiac interventions.
Are there any specific storage instructions provided for the Soundstar 3D Ultrasound Catheter Model M-5723-12?
The provided data does not specify detailed storage conditions for the Soundstar 3D Ultrasound Catheter Model M-5723-12. Clinicians should follow general guidelines for storing medical devices, such as keeping them in a clean, dry environment away from direct sunlight and extreme temperatures until use.
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 by BIOSENSE WEBSTER ..., 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 | K101138 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biosense Webster Inc
- FDA Applicant
- Biosense Webster, Inc.
Sources (1)
- FDA 510(k) K101138 24 fields · synced Oct 1, 2026