Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12— 510(k) K192981

Substantially Equivalent

Penumbra, Inc.

FDA 510(k) clearance K192981 for Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12, Substantially Equivalent on 2020-05-28. Applicant: Penumbra, Inc..

Clearance details

Applicant: Penumbra, Inc.
Product code: Code QEW
Advisory panel: Cardiovascular
Date received: 2019-10-24
Decision date: 2020-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alameda, CA, US

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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.