AVERT Contrast Modulation System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K150485 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 Injector and Syringe, Angiographic (Device Class II) designed to facilitate the controlled infusion of radiopaque contrast media during angiographic procedures. It integrates a secondary fluid pathway to dynamically adjust system resistance, enabling precise modulation of contrast flow during manual or automated injections. This aids in optimizing image quality while reducing contrast agent usage in coronary and peripheral angiographic applications.
The system is intended for physician use in clinical settings such as cardiac catheterization labs and interventional radiology suites. Supplied as a reusable medical device, it requires proper sterilization and maintenance per manufacturer guidelines. The AVERT System is FDA-cleared under 510(k) K150485, with a Special 510(k) designation and Substantially Equivalent determination by the FDA’s Cardiovascular Advisory Committee. No MRI safety or single-use specifications are noted in the regulatory data.
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 CONSERVATION SYSTEM by OSPREY MEDICAL, INC. | FDA 510 (k) Summary
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K150485 | Class II | Active |
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Manufacturer
- Manufacturer
- Osprey Medical, Inc.
Sources (1)
- FDA 510(k) K150485 24 fields · synced Oct 1, 2026