SoundStar Eco 8F Ultrasound Catheter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K140318 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 Eco 8F Ultrasound Catheter is a steerable, flexible tube with an ultrasonic phased-array imaging transducer at its distal tip designed for intracardiac echocardiography. It enables visualization of cardiac anatomy and physiology, and can visualize other devices within the heart and possibly great vessels such as the pulmonary artery.
This device is supplied as a single-use catheter and is not MRI safe. It is authorized under FDA 510(k) clearance with the product code OBJ and is manufactured by Biosense Webster. The device is intended for use in cardiovascular procedures and is regulated under 870.1200.
Frequently asked questions
What is the SoundStar Eco 8F Ultrasound Catheter used for?
It is designed for intracardiac echocardiography to visualize cardiac anatomy and physiology, and can also image other devices within the heart and possibly great vessels such as the pulmonary artery during cardiovascular procedures.
Is the SoundStar Eco 8F Ultrasound Catheter reusable or single-use?
The device is supplied as a single-use catheter and is not intended for reuse, as stated in its specifications to ensure patient safety and optimal performance.
What regulatory pathway was used for the SoundStar Eco 8F Ultrasound Catheter?
It received FDA 510(k) clearance under product code OBJ, with a special clearance type and decision date of March 12, 2014, based on substantial equivalence to a predicate device.
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™ Ultrasound Catheter | J&J MedTech US, SoundStar eco 8F G Catheter - - Physicians Office Resource, Reprocessed SoundStar ultrasound catheter | Stryker
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K140318 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biosense Webster
Sources (1)
- FDA 510(k) K140318 24 fields · synced Oct 6, 2026