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Revolution 45 MHz Rotational Intravascular Ultrasound Imaging Catheter

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K050995

by Volcano Corporation

Identifiers

510(k) Number
K050995 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 Revolution 45 MHz Rotational Intravascular Ultrasound Imaging Catheter is a rotational intravascular ultrasound (IVUS) catheter designed for intravascular imaging. It provides detailed cross-sectional views of blood vessels, enabling assessment of coronary and peripheral arteries to evaluate lumen dimensions, plaque composition, and vessel wall integrity.

This device is intended for single-use in clinical settings such as catheterization laboratories. Supplied sterile, it is classified as a Class II medical device under the FDA’s 510(k) pathway and adheres to the Medical Device Directive (MDD). The catheter is available in various sizes and configurations, as referenced by the associated FEI numbers, and must be handled according to manufacturer guidelines to ensure proper imaging and sterility. No MRI safety information is specified.

Frequently asked questions

What types of blood vessels can the Revolution 45 MHz Rotational IVUS Imaging Catheter be used to image, and why is this important for clinical assessment?

The Revolution 45 MHz Rotational IVUS Imaging Catheter is designed for intravascular imaging of coronary and peripheral arteries. This is important because it allows clinicians to assess lumen dimensions, plaque composition, and vessel wall integrity in both heart-related (coronary) and non-heart-related (peripheral) blood vessels, aiding in the diagnosis and treatment planning for conditions like atherosclerosis, stenosis, or vascular disease.

Is the Revolution 45 MHz Rotational IVUS Imaging Catheter intended for reuse, or is it single-use only? How does this affect handling and sterility?

The device is intended for single-use only in clinical settings like catheterization laboratories. This design ensures sterility is maintained throughout its use, as it is supplied sterile and must not be reused. Proper handling—such as avoiding contamination before use—is critical to preserve imaging quality and prevent infection.

What does the wide range of FEI numbers (e.g., 3011763071, 3008497357) indicate about the available sizes or configurations of this catheter?

The listed FEI numbers represent various sizes and configurations of the Revolution 45 MHz Rotational IVUS Imaging Catheter, tailored to different clinical needs. These variations likely account for differences in catheter diameter, length, or imaging frequency requirements, allowing for compatibility with diverse patient anatomies and procedural preferences.

How should the Revolution 45 MHz Rotational IVUS Imaging Catheter be stored to ensure optimal performance and sterility?

Since the catheter is supplied sterile, it must be stored in its original packaging until use to maintain sterility. Storage conditions should follow manufacturer guidelines, typically involving protection from moisture, extreme temperatures, and physical damage. Avoid exposing it to contaminants or environmental stressors that could compromise imaging quality or sterility.

What regulatory pathways does the Revolution 45 MHz Rotational IVUS Imaging Catheter follow, and what does this mean for clinicians or buyers?

The device is cleared via the FDA’s 510(k) pathway (Class II) and complies with the Medical Device Directive (MDD). This means it has undergone regulatory review to demonstrate safety and effectiveness for its intended use, providing assurance of its clinical reliability. Buyers and clinicians can rely on its compliance with these standards when selecting or utilizing the 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 (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Volcano Corporation

Sources (2)

  • FDA 510(k) K050995 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026