Ocelot III

AVINGER, INC. · Model O200 · UDI-DI 00851354004189

NQQ DQY Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

The Ocelot System is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including sub and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen and wall structures. The Ocelot System is contraindicated for use in the iliac, coronary, cerebral, renal or carotid vasculature.

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.