Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister— 510(k) K180412

Substantially Equivalent

Penumbra, Inc.

FDA 510(k) clearance K180412 for Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister, Substantially Equivalent on 2018-05-15. Applicant: Penumbra, Inc..

Clearance details

Applicant: Penumbra, Inc.
Product code: Code QEW
Advisory panel: Cardiovascular
Date received: 2018-02-15
Decision date: 2018-05-15
Decision: Substantially Equivalent
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.