Heartware Intl. Corp.
United StatesFDA applicant, unverified
- Devices
- 4
What Heartware Intl. Corp. makes
Heartware Intl. Corp. develops diagnostic software and systems for cardiovascular imaging and electrophysiology, including coronary angiography analysis tools, ventricular function assessment software, and electrophysiology diagnostic platforms.
The company’s products are classified as Class II medical devices and are listed under FDA’s 510(k) pathway. These devices are based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Hb 1000, Brugada Electrophysiology System Ref K893094
Regimes: 510(k) Registry: 510(k)Hearttrace Left Ventricular Analysis Software Ref K933073
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Heartware Intl. Corp. have in the registry?
The registry currently lists 4 devices for Heartware Intl. Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Heartware Intl. Corp.'s devices?
Among its 4 most recently registered devices, Heartware Intl. Corp. has devices listed in FDA 510(k) (4 devices).
What risk classes do Heartware Intl. Corp.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Heartware Intl. Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Heartware Intl. Corp. in the registry?
The most recently registered devices listed for Heartware Intl. Corp. include HEARTVIEW(R) CORONARY ANGIOGRAPH DIAGRAM/REPORT SY, HEARTTRACK QUANTITATIVE CORONARY ANGIOGRAPHY SOFTW, HB 1000, BRUGADA ELECTROPHYSIOLOGY SYSTEM and HEARTTRACE LEFT VENTRICULAR ANALYSIS SOFTWARE.