Pantheris

AVINGER, INC. · Model A400X · UDI-DI 00851354004387

NQQ MCW Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

The Pantheris System is intended to remove plaque (atherectomy) from partially occluded vessels in the peripheral vasculature with a reference diameter of 3.0 mm to 7.0 mm, using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen, wall structures and vessel morphologies.

Recalls

Date	Firm	Reason
2018-04-11	Ninepoint Medical Inc.	Distal tips of the probes may detach from the probe shaft during use.
2011-12-22	Imalux Corporation	During an FDA inspection, the firm was notified that the wrong tubing was used during the manufacture of the probe for the unit.
2010-07-20	Optovue Inc.	Use of the CAM attachment may result in a positioning anomaly and mistreatment in the eyes of the patient.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.