Revolution 45MHZ IVUS Imaging Catheter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K080891 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)
This device is an intravascular ultrasound (IVUS) imaging catheter designed for use in cardiovascular applications. It operates at a frequency of 45 MHz to provide high-resolution imaging of blood vessel walls from within the lumen.
The catheter is supplied as a single-use, sterile device intended for use in clinical settings such as catheterization laboratories. It is authorized under FDA 510(k) clearance (K080891) and is classified as a Class II medical device under regulation number 870.1200 with product code OBJ.
Frequently asked questions
What is the REVOLUTION 45MHZ IVUS Imaging Catheter used for?
This device is designed for intravascular ultrasound imaging in cardiovascular applications, using a 45 MHz frequency to produce high-resolution images of blood vessel walls from within the lumen, aiding in diagnostic and interventional procedures.
How is the REVOLUTION 45MHZ IVUS Imaging Catheter supplied and is it reusable?
The catheter is supplied as a single-use, sterile device, meaning it is intended for one patient only and must be discarded after use; it is not designed for cleaning, reprocessing, or reuse due to infection risk and performance integrity.
What regulatory authorization does the REVOLUTION 45MHZ IVUS Imaging Catheter have?
The device is authorized under FDA 510(k) clearance with K-number K080891, classified as a Class II medical device under regulation 870.1200 with product code OBJ, indicating it is substantially equivalent to a legally marketed 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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K080891 | Class II | Active |
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Manufacturer
- Manufacturer
- Volcano Corporation
Sources (1)
- FDA 510(k) K080891 24 fields · synced Sep 21, 2026