Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled— 510(k) K162326

Substantially Equivalent

Avinger, Inc.

FDA 510(k) clearance K162326 for Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled, Substantially Equivalent on 2016-10-18. Applicant: Avinger, Inc..

Clearance details

Applicant: Avinger, Inc.
Product code: Code MCW
Advisory panel: Cardiovascular
Date received: 2016-08-19
Decision date: 2016-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redwood City, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MCW

product code MCW

Death: 38
Injury: 1,386
Malfunction: 2,676
Other: 2
Total: 4,102

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.