HEARTTRACE LEFT VENTRICULAR ANALYSIS SOFTWARE— 510(k) K933073

Name: FDA 510(k) clearance K933073
Creator: U.S. Food and Drug Administration
Published: 1993-10-07

Substantially Equivalent

Heartware Intl. Corp.

FDA 510(k) clearance K933073 for HEARTTRACE LEFT VENTRICULAR ANALYSIS SOFTWARE, Substantially Equivalent on 1993-10-07. Applicant: Heartware Intl. Corp.. Device class: 2.

Clearance details

Applicant: Heartware Intl. Corp.
Product code: Code IZI
Device class: Class 2
Regulation: 21 CFR 892.1600
Advisory panel: Radiology
Date received: 1993-06-23
Decision date: 1993-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code IZI

product code IZI

Death: 9
Malfunction: 5,312
Total: 5,321

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.