Identifiers
- 510(k) Number
- K182341 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)
Pantheris SV is a catheter-based atherectomy device designed for the diagnosis and treatment of Peripheral Artery Disease (PAD). It is an image-guided system intended for use in vascular procedures.
The device is supplied sterile and is intended for single use. It is a Class II medical device regulated under 870.4875 and has received FDA 510(k) clearance (K182341).
Frequently asked questions
What is the Pantheris SV used for?
The Pantheris SV is a catheter-based atherectomy device designed for the diagnosis and treatment of Peripheral Artery Disease (PAD). It is an image-guided system used in vascular procedures.
Is the Pantheris SV intended for single use?
Yes, the device is supplied sterile and is intended for single use. It is not designed for reuse.
What is the regulatory status of the Pantheris SV?
The Pantheris SV is a Class II medical device regulated under regulation number 870.4875. It has received FDA 510(k) clearance (K182341).
How is the Pantheris SV supplied?
The device is supplied sterile, ready for use in a single-use configuration.
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 Announces Full Commercial Launch of Pantheris SV, Avinger Announces Full Commercial Launch of Pantheris SV, Avinger, Inc. Receives FDA Clearance of Pantheris Sv Device
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K182341 | Class II | Active |
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Manufacturer
- Manufacturer
- Avinger, Inc.
Sources (1)
- FDA 510(k) K182341 24 fields · synced Sep 25, 2026