ProtekDuo Veno-Venous Cannula Sets— 510(k) K232480

Name: FDA 510(k) clearance K232480
Creator: U.S. Food and Drug Administration
Published: 2023-10-06

Substantially Equivalent

Cardiacassist, Inc.

FDA 510(k) clearance K232480 for ProtekDuo Veno-Venous Cannula Sets, Substantially Equivalent on 2023-10-06. Applicant: Cardiacassist, Inc.. Device class: 2.

Clearance details

Applicant: Cardiacassist, Inc.
Product code: Code PZS
Device class: Class 2
Regulation: 21 CFR 870.4100
Advisory panel: Cardiovascular
Date received: 2023-08-16
Decision date: 2023-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pittsburg, PA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code PZS

product code PZS

Death: 17
Total: 17

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.