Heartware Intl. Corp.

FDA Regulatory Profile

Heartware Intl. Corp. appears in FDA public data with 0 recalls, 4 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on December 13, 1993.

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