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

Name: FDA 510(k) clearance K162326
Creator: U.S. Food and Drug Administration
Published: 2016-10-18

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.. Device class: 2.

Clearance details

Applicant: Avinger, Inc.
Product code: Code MCW
Device class: Class 2
Regulation: 21 CFR 870.4875
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 ↗

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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.