Soundstar 3D Diagnostic Catheter, Model M-5723-05
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K091352 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 Diagnostic Catheter, Model M-5723-05, is an intravascular ultrasound catheter designed for intracardiac and intraluminal visualization. It integrates three-dimensional imaging capabilities to provide detailed visualization of cardiac structures and blood vessels, aiding in diagnostic assessments during interventional procedures.
This device is intended for single-use and is classified as a Class II medical device under FDA regulations. It is supplied sterile and is used in cardiac catheterization laboratories for real-time imaging of coronary arteries and cardiac chambers. The catheter’s design adheres to MRI safety standards for non-MRI environments, and its specifications are authorized under FDA 510(k) clearance (K091352)
Frequently asked questions
What is the primary use of the Soundstar 3D Diagnostic Catheter, Model M-5723-05, in a clinical setting?
The Soundstar 3D Diagnostic Catheter, Model M-5723-05, is designed for intracardiac and intraluminal visualization during interventional procedures. It provides detailed three-dimensional imaging of cardiac structures and blood vessels, specifically coronary arteries and cardiac chambers, to aid in diagnostic assessments within cardiac catheterization laboratories.
Is the Soundstar 3D Diagnostic Catheter, Model M-5723-05, intended for reuse or is it single-use only?
The Soundstar 3D Diagnostic Catheter, Model M-5723-05, is explicitly intended for single-use only, as stated in its description. This ensures patient safety and sterility during diagnostic procedures.
How is the Soundstar 3D Diagnostic Catheter, Model M-5723-05, supplied, and what does that mean for its handling?
The Soundstar 3D Diagnostic Catheter, Model M-5723-05, is supplied sterile, meaning it is pre-sterilized and packaged to maintain sterility until use. This allows for immediate use in sterile environments like cardiac catheterization labs without additional sterilization steps.
What regulatory pathway was followed for the FDA clearance of the Soundstar 3D Diagnostic Catheter, Model M-5723-05?
The Soundstar 3D Diagnostic Catheter, Model M-5723-05, received FDA clearance through a 510(k) pathway, specifically classified as a Special clearance under the Cardiovascular advisory committee. The device was determined to be substantially equivalent to a predicate product, with clearance number K091352.
Can the Soundstar 3D Diagnostic Catheter, Model M-5723-05, be used in environments where MRI equipment is present?
The Soundstar 3D Diagnostic Catheter, Model M-5723-05, adheres to MRI safety standards but is explicitly designed for use in non-MRI environments. This means it should not be used in areas where MRI machines are operational, as its safety in such settings has not been validated.
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 Diagnostic Catheter, Model M-5723-05 (K091352) — Fda 510 ..., Soundstar 3d Ultrasound Catheter, Model M-5723-05, SOUNDSTAR 3D DIAGNOSTIC CATHETER, MODEL M-5723-05… - FDA.report, Soundstar 3d Diagnostic Catheter, Model M-5723-05 - Beudamed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K091352 | Class II | Active |
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Manufacturer
- Manufacturer
- Biosense Webster Inc
- FDA Applicant
- Biosense Webster, Inc.
Sources (1)
- FDA 510(k) K091352 24 fields · synced Sep 19, 2026