Penumbra System (Reperfusion Catheter RED 62)— 510(k) K203440

Substantially Equivalent

Penumbra, Inc.

FDA 510(k) clearance K203440 for Penumbra System (Reperfusion Catheter RED 62), Substantially Equivalent on 2021-05-20. Applicant: Penumbra, Inc..

Clearance details

Applicant: Penumbra, Inc.
Product code: Code NRY
Advisory panel: Cardiovascular
Date received: 2020-11-23
Decision date: 2021-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alameda, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NRY

product code NRY

Death: 411
Injury: 1,712
Malfunction: 1,855
Total: 3,978

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.