HEART PACK III— 510(k) K914933

Name: FDA 510(k) clearance K914933
Creator: U.S. Food and Drug Administration
Published: 1992-01-31

Unknown

Westmark Hospital Supplies

FDA 510(k) clearance K914933 for HEART PACK III, Unknown on 1992-01-31. Applicant: Westmark Hospital Supplies. Device class: 2.

Clearance details

Applicant: Westmark Hospital Supplies
Product code: Code KOD
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1991-11-04
Decision date: 1992-01-31
Decision: Unknown
Clearance type: Traditional
Location: Grand Rapids, MI, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KOD

product code KOD

Death: 5
Injury: 1,129
Malfunction: 7,019
Total: 8,153

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.