Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7— 510(k) K210083

Substantially Equivalent

Penumbra, Inc.

FDA 510(k) clearance K210083 for Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7, Substantially Equivalent on 2021-02-09. Applicant: Penumbra, Inc..

Clearance details

Applicant: Penumbra, Inc.
Product code: Code QEW
Advisory panel: Cardiovascular
Date received: 2021-01-12
Decision date: 2021-02-09
Decision: Substantially Equivalent
Clearance type: Special
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.