Silicon Vally Medical Instruments, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Silicon Vally Medical Instruments, Inc. makes
Silicon Valley Medical Instruments, Inc. manufactures intravascular ultrasound (IVUS) imaging systems and catheters, including the HD-IVUS system and the Kodama IVUS catheter. These devices provide real-time cross-sectional imaging of blood vessels to assess plaque buildup, vessel dimensions, and stent placement during cardiac and vascular procedures.
The company’s portfolio consists of Class II medical devices, authorised via the FDA’s 510(k) pathway. Products are listed under the FDA’s regulatory framework and are intended for use in the United States.
Catalogue
Hd-Ivus Ultrasound Imaging System Ref K112997
Regimes: 510(k) Registry: 510(k)Kodama Intravascular Ulrasound Catheter Ref K113008
Regimes: 510(k) Registry: 510(k)Hd-Ivus Ultrasound Imaging System Ref K122878
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Silicon Vally Medical Instruments, Inc. have in the registry?
The registry currently lists 3 devices for Silicon Vally Medical Instruments, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Silicon Vally Medical Instruments, Inc.'s devices?
Among its 3 most recently registered devices, Silicon Vally Medical Instruments, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Silicon Vally Medical Instruments, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Silicon Vally Medical Instruments, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Silicon Vally Medical Instruments, Inc. in the registry?
The most recently registered devices listed for Silicon Vally Medical Instruments, Inc. include HD-IVUS ULTRASOUND IMAGING SYSTEM and KODAMA INTRAVASCULAR ULRASOUND CATHETER.