Atherectomy
Pantheris SV
An assembly of devices intended to mechanically disrupt/remove atheroma plaque from the walls of both coronary and peripheral arteries. It typically includes a mains electricity (AC-powered) energy-producing generator with monitoring functions, a remote control or foot-switch, a handpiece (to which the catheter connects) and a dedicated disposable catheter with a cutting or abrasive head that transmits the mechanical energy to the atheroma. The system may include an integrated irrigation/suction system and includes/requires accessory devices for its function (e.g., saline/lubricant, pump, guidewire).
Pantheris SV models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| A140-SV | — | Not stated | Available |
FDA clearances
- 510(k) K182341 April 2019
Procedures that use atherectomy
Frequently asked questions
What is Pantheris SV used for?
An assembly of devices intended to mechanically disrupt/remove atheroma plaque from the walls of both coronary and peripheral arteries. It typically includes a mains electricity (AC-powered) energy-producing generator with monitoring functions, a remote control or foot-switch, a handpiece (to which the catheter connects) and a dedicated disposable catheter with a cutting or abrasive head that transmits the mechanical energy to the atheroma. The system may include an integrated irrigation/suction system and includes/requires accessory devices for its function (e.g., saline/lubricant, pump, guidewire).
Who makes Pantheris SV?
Pantheris SV is made by Avinger, Inc.. It is listed under atherectomy devices in our device library.
What sizes does Pantheris SV come in?
The FDA device database does not list sizes for Pantheris SV. Check the instructions for use or ask a Avinger, Inc. representative.
Is Pantheris SV MRI safe?
The FDA device database entry for Pantheris SV does not state its MRI safety status. Check the labeling before MRI.
Is Pantheris SV FDA cleared?
Pantheris SV is covered by FDA submission K182341.
How do I contact a Avinger, Inc. sales representative?
Avinger, Inc. has not listed representatives on LA Vascular yet. Visit the Avinger, Inc. company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.