HEARTTRACK QUANTITATIVE CORONARY ANGIOGRAPHY SOFTW— 510(k) K933058

Substantially Equivalent

Heartware Intl. Corp.

FDA 510(k) clearance K933058 for HEARTTRACK QUANTITATIVE CORONARY ANGIOGRAPHY SOFTW, Substantially Equivalent on 1993-09-28. Applicant: Heartware Intl. Corp..

Clearance details

Applicant: Heartware Intl. Corp.
Product code: Code IZI
Advisory panel: Radiology
Date received: 1993-06-22
Decision date: 1993-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

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.