K123532

Substantially Equivalent

OCELOT PIXL CATHETER

Applicant: Avinger, Inc.
Product code: PDU
Advisory panel: Cardiovascular
Date received: 2012-11-16
Decision date: 2012-12-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Redwood City, CA, US

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.