PENUMBRA SYSTEM SEPARATOR FLEX (026,032,041,054), MODELS PSF026, PSF032, PSF041, PSF054— 510(k) K100769

Substantially Equivalent

Penumbra, Inc.

FDA 510(k) clearance K100769 for PENUMBRA SYSTEM SEPARATOR FLEX (026,032,041,054), MODELS PSF026, PSF032, PSF041, PSF054, Substantially Equivalent on 2010-05-21. Applicant: Penumbra, Inc..

Clearance details

Applicant: Penumbra, Inc.
Product code: Code NRY
Advisory panel: Cardiovascular
Date received: 2010-03-18
Decision date: 2010-05-21
Decision: Substantially Equivalent
Clearance type: Special
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.