K193595

Substantially Equivalent

Indigo Aspiration System - Aspiration Catheter 7 and Separator 7

Applicant: Penumbra, Inc.
Product code: QEW
Advisory panel: Cardiovascular
Date received: 2019-12-23
Decision date: 2020-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alameda, CA, US

Adverse events under product code QEW

product code QEW

Death: 126
Injury: 282
Malfunction: 820
Total: 1,228

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.