Penumbra System ACE 68 Reperfusion Catheter— 510(k) K161064

Substantially Equivalent

Penumbra, Inc.

FDA 510(k) clearance K161064 for Penumbra System ACE 68 Reperfusion Catheter, Substantially Equivalent on 2016-06-12. Applicant: Penumbra, Inc..

Clearance details

Applicant: Penumbra, Inc.
Product code: Code NRY
Advisory panel: Cardiovascular
Date received: 2016-04-15
Decision date: 2016-06-12
Decision: Substantially Equivalent
Clearance type: Special
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.