Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled— 510(k) K172236

Substantially Equivalent

Avinger, Inc.

FDA 510(k) clearance K172236 for Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled, Substantially Equivalent on 2017-10-30. Applicant: Avinger, Inc..

Clearance details

Applicant: Avinger, Inc.
Product code: Code MCW
Advisory panel: Cardiovascular
Date received: 2017-07-25
Decision date: 2017-10-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Redwood City, CA, US

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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.