Pantheris System— 510(k) K152275

Substantially Equivalent

Avinger, Inc.

FDA 510(k) clearance K152275 for Pantheris System, Substantially Equivalent on 2015-10-14. Applicant: Avinger, Inc..

Clearance details

Applicant: Avinger, Inc.
Product code: Code MCW
Advisory panel: Cardiovascular
Date received: 2015-08-12
Decision date: 2015-10-14
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.