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Heartware Intl. Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
4
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K932410HEARTVIEW(R) CORONARY ANGIOGRAPH DIAGRAM/REPORT SYDecember 13, 1993
K933073HEARTTRACE LEFT VENTRICULAR ANALYSIS SOFTWAREOctober 7, 1993
K933058HEARTTRACK QUANTITATIVE CORONARY ANGIOGRAPHY SOFTWSeptember 28, 1993
K893094HB 1000, BRUGADA ELECTROPHYSIOLOGY SYSTEMOctober 2, 1989