K122756

Substantially Equivalent

PENUMBRA PUMP MAX (110VAC), PENUMBRA PUMP MAX (230VAC), PENUMBAR PUMP MAX CANISTER/TUBING

Applicant: Penumbra, Inc.
Product code: JCX
Advisory panel: General, Plastic Surgery
Date received: 2012-09-07
Decision date: 2012-10-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Alameda, CA, US

Adverse events under product code JCX

product code JCX

Death: 11
Malfunction: 838
Other: 1
Total: 850

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.