AVERT Contrast Modulation System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K151300 FDA 510(k)
- FDA Product Code
- DXT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1650 FDA 510(k)
- Regulation Number
- 870.1650 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The AVERT Contrast Modulation System is an angiographic injector and syringe device designed for controlled infusion of radiopaque contrast media during coronary and peripheral angiographic procedures. It functions as a mechanical system to deliver precise contrast volumes while allowing secondary fluid pathway modulation to adjust system resistance during manual contrast administration.
This device is intended for use in clinical settings by physicians, supplying pre-filled syringes or contrast media containers for angiographic imaging. It is classified as a Class II medical device under FDA regulations (870.1650) and has received a 510(k) clearance (K151300) for traditional review. The system is reusable and not intended for MRI use. No sterility or single-use specifications are explicitly stated in the provided data.
Frequently asked questions
What is the AVERT Contrast Modulation System used for?
The AVERT Contrast Modulation System is designed specifically for angiographic procedures, enabling controlled infusion of radiopaque contrast media during coronary and peripheral angiography. Its mechanical system ensures precise volume delivery while allowing secondary fluid pathway modulation to adjust system resistance, which aids in manual contrast administration for clearer imaging.
How is the AVERT Contrast Modulation System supplied for clinical use?
The system is intended for use in clinical settings by physicians and is compatible with pre-filled syringes or contrast media containers. It is a reusable device, meaning it can be used across multiple procedures after proper cleaning and maintenance, rather than being single-use.
Is the AVERT Contrast Modulation System sterile or single-use?
The provided data does not explicitly specify sterility or single-use requirements for the AVERT Contrast Modulation System. Clinicians should follow manufacturer guidelines for cleaning, maintenance, and reprocessing to ensure safe reuse. Always verify with Osprey Medical’s instructions for proper handling.
Can the AVERT Contrast Modulation System be used in MRI environments?
No, the AVERT Contrast Modulation System is explicitly not intended for MRI use. Its design and materials are optimized for angiographic procedures in standard clinical settings, not magnetic resonance imaging environments.
What regulatory approval does the AVERT Contrast Modulation System hold?
The AVERT Contrast Modulation System has received FDA 510(k) clearance (K151300) under traditional review, confirming it meets regulatory standards for Class II medical devices. This clearance is specific to its intended use in angiographic procedures and does not imply approval for other applications.
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: AVERT Contrast Modulation System (K151300) — FDA 510 (k) | Innolitics, AVERT Contrast Modulation System;AVERT Contrast Modulation System;AVERT ..., K152218 FDA 510 (k) - AVERT Contrast Modulation System, Contrast Media Volume Control and Acute Kidney Injury in ... - JSCAI
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K151300 | Class II | Active |
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Manufacturer
- Manufacturer
- Osprey Medical, Inc.
Sources (1)
- FDA 510(k) K151300 24 fields · synced Oct 1, 2026