Tigereye ST CTO-Crossing Catheter— 510(k) K230594

Substantially Equivalent

Avinger, Inc.

FDA 510(k) clearance K230594 for Tigereye ST CTO-Crossing Catheter, Substantially Equivalent on 2023-04-25. Applicant: Avinger, Inc..

Clearance details

Applicant: Avinger, Inc.
Product code: Code PDU
Advisory panel: Cardiovascular
Date received: 2023-03-03
Decision date: 2023-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redwood City, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code PDU

product code PDU

Malfunction: 793
Total: 793

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.