PENUMBRA ASPIRATION PUMP, MODEL 115V— 510(k) K051758

Substantially Equivalent

Penumbra, Inc.

FDA 510(k) clearance K051758 for PENUMBRA ASPIRATION PUMP, MODEL 115V, Substantially Equivalent on 2005-08-17. Applicant: Penumbra, Inc..

Clearance details

Applicant: Penumbra, Inc.
Product code: Code BTA
Advisory panel: General, Plastic Surgery
Date received: 2005-06-29
Decision date: 2005-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Leandro, CA, US

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Adverse events under product code BTA

product code BTA

Death: 5
Total: 5

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.