INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)— 510(k) K220683

Unknown

Penumbra, Inc.

FDA 510(k) clearance K220683 for INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4), Unknown on 2022-10-04. Applicant: Penumbra, Inc..

Clearance details

Applicant: Penumbra, Inc.
Product code: Code QEW
Advisory panel: Cardiovascular
Date received: 2022-03-08
Decision date: 2022-10-04
Decision: Unknown
Clearance type: Traditional
Location: Alameda, CA, US

Download summary PDF View on FDA.gov ↗

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.