# Heartware Intl. Corp.

- Location (FDA's records): North Attleboro, MA
- FDA decisions: 4 (1989–1993): 4 510(k) clearances
- Product codes: IZI (3), JOQ (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- K932410: Heartview (R) Coronary Angiograph Diagram/Report SY (Dec 13, 1993)
- K933073: Hearttrace Left Ventricular Analysis Software (Oct 7, 1993)
- K933058: Hearttrack Quantitative Coronary Angiography Softw (Sep 28, 1993)
- K893094: HB 1000, Brugada Electrophysiology System (Oct 2, 1989)

Source page: https://510kreport.com/company/heartware-intl