Keystone Heart, Ltd.
IsraelFDA applicant, unverified
- Devices
- 2
What Keystone Heart, Ltd. makes
Keystone Heart, Ltd. manufactures single-use vascular guide-catheters designed for transseptal procedures, including steerable transseptal catheters, sheaths, and dilators. These devices are intended for precise navigation within cardiac anatomy during interventions like ablation or valve repairs.
The company’s products are classified as Class II medical devices under FDA regulations and are authorised via 510(k) premarket notifications and the Unique Device Identifier (UDI) system. The portfolio is listed in the FDA’s regulatory databases, and the company is based in the United States.
Catalogue
- Registry: GUDID
- Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 649822251
Frequently asked questions
How many devices does Keystone Heart, Ltd. have in the registry?
The registry currently lists 2 devices for Keystone Heart, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Keystone Heart, Ltd.'s devices?
Among its 2 most recently registered devices, Keystone Heart, Ltd. has devices listed in FDA 510(k) (1 device) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Keystone Heart, Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Keystone Heart, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Keystone Heart, Ltd. in the registry?
The most recently registered devices listed for Keystone Heart, Ltd. include XactTS Steerable Transseptal Catheter SS-001 and Lim Precision Steerable TS, Steerable Sheath, Dilator.