Medical Device Manufacturer · US , New York , NY

Heartware Intl. Corp. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 1989

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Heartware Intl. Corp. Radiology ✕

3 devices

1-3 of 3

Cleared Dec 13, 1993

HEARTVIEW(R) CORONARY ANGIOGRAPH DIAGRAM/REPORT SY

Radiology · 209d

Cleared Oct 07, 1993

HEARTTRACE LEFT VENTRICULAR ANALYSIS SOFTWARE

Radiology · 106d

Cleared Sep 28, 1993

HEARTTRACK QUANTITATIVE CORONARY ANGIOGRAPHY SOFTW

Radiology · 98d