Heart Technology, Inc.
United StatesFDA applicant, unverified
- Devices
- 7
What Heart Technology, Inc. makes
Heart Technology, Inc. manufactures electrophysiological devices used in cardiac ablation procedures, including the Rotablator wireclip and its modifications, which facilitate tissue ablation and lesion formation in the heart. These tools are designed for use with the Rotablator system, a high-speed rotary device for treating calcified coronary arteries and structural heart lesions.
The company’s portfolio is classified under FDA Class II devices, with each product authorised via the 510(k) pathway. These devices are listed in the FDA’s 510(k) registry, reflecting their regulatory clearance for commercial distribution in the United States.
Catalogue
Rotablator Rotational Angioplasty System Rotablator System's Guide Wire Line; Hti Floppy Ref K954604
Regimes: 510(k) Registry: 510(k)Rotablator Rotational Angioplasty Ref K953997
Regimes: 510(k) Registry: 510(k)Heart Technology Rotablator Wireclip Ref K913450
Regimes: 510(k) Registry: 510(k)Rotablator Ref K901206
Regimes: 510(k) Registry: 510(k)Heart Technology Wireclip Ref K914581
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Rotablator, Modification Ref K933238
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Heart Technology, Inc. have in the registry?
The registry currently lists 7 devices for Heart Technology, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Heart Technology, Inc.'s devices?
Among its 7 most recently registered devices, Heart Technology, Inc. has devices listed in FDA 510(k) (7 devices).
What risk classes do Heart Technology, Inc.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Heart Technology, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Heart Technology, Inc. in the registry?
The most recently registered devices listed for Heart Technology, Inc. include ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM ROTABLATOR SYSTEM'S GUIDE WIRE LINE; HTI FLOPPY, ROTABLATOR ROTATIONAL ANGIOPLASTY, HEART TECHNOLOGY ROTABLATOR WIRECLIP and ROTABLATOR.