Identifiers
- 510(k) Number
- K152275 FDA 510(k)
- FDA Product Code
- MCW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.4875 FDA 510(k)
- Regulation Number
- 870.4875 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Pantheris System is a catheter-based, intravascular image-guided atherectomy device designed for the treatment of peripheral artery disease. It integrates optical coherence tomography imaging with directional atherectomy to allow real-time visualization and removal of plaque from arterial lesions.
The device is supplied as a single-use, sterile system and is intended for use in a clinical setting under fluoroscopic and intravascular imaging guidance. It is classified as a Class II peripheral atherectomy catheter and is regulated under product code MCW. The system is not evaluated for MRI compatibility and should be stored in a dry environment at room temperature prior to use.
Frequently asked questions
What is the Pantheris System used for?
It is a catheter-based, intravascular image-guided atherectomy device designed to treat peripheral artery disease by enabling real-time visualization and removal of plaque from arterial lesions.
How is the Pantheris System supplied?
It is supplied as a single-use, sterile system intended for clinical use under fluoroscopic and intravascular imaging guidance.
Is the Pantheris System reusable?
No, it is a single-use device and must not be reused. Reuse or reprocessing could compromise sterility and device integrity.
How should the Pantheris System be stored?
It should be stored in a dry environment at room temperature prior to use. It is not evaluated for MRI compatibility, so it must not be exposed to magnetic fields.
What regulatory classification does the Pantheris System have?
It is classified as a Class II peripheral atherectomy catheter under product code MCW and is regulated under FDA 510(k) regulations.
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: Avinger's Pantheris LV Image-Guided Atherectomy System Receives FDA 510 ..., Avinger Initiates Full Commercial Launch of Pantheris LV Image ... - Nasdaq, Avinger Initiates Full Commercial Launch of Pantheris LV Image-Guided ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K152275 | Class II | Active |
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Manufacturer
- Manufacturer
- Avinger, Inc.
Sources (1)
- FDA 510(k) K152275 24 fields · synced Sep 28, 2026