Penumbra System ACE 64 and ACE 68 Reperfusion Catheters— 510(k) K152541

Substantially Equivalent

Penumbra, Inc.

FDA 510(k) clearance K152541 for Penumbra System ACE 64 and ACE 68 Reperfusion Catheters, Substantially Equivalent on 2016-01-13. Applicant: Penumbra, Inc..

Clearance details

Applicant: Penumbra, Inc.
Product code: Code NRY
Advisory panel: Cardiovascular
Date received: 2015-09-04
Decision date: 2016-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alameda, CA, US

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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.