POLYSTAN VERTICLUDE BLOOD PUMP— 510(k) K813035

Name: FDA 510(k) clearance K813035
Creator: U.S. Food and Drug Administration
Published: 1981-11-27

Substantially Equivalent

Advocacy International, Ltd.

FDA 510(k) clearance K813035 for POLYSTAN VERTICLUDE BLOOD PUMP, Substantially Equivalent on 1981-11-27. Applicant: Advocacy International, Ltd.. Device class: 2.

Clearance details

Applicant: Advocacy International, Ltd.
Product code: Code DWB
Device class: Class 2
Regulation: 21 CFR 870.4370
Advisory panel: Cardiovascular
Date received: 1981-10-28
Decision date: 1981-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DWB

product code DWB

Death: 2
Total: 2

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.