Ovalum, Ltd.
IsraelFDA 510(k) applicant, unverified
- Devices
- 1
What Ovalum, Ltd. makes
Ovalum, Ltd. manufactures coronary guidewires, including the CITOP10 (0.014-inch tip) and CITOP6 (0.014-inch tip, 1.0mm), as well as a 0.023-inch support accessory for coronary interventions. These devices are designed for use in percutaneous coronary procedures, providing structural support and navigation within coronary arteries.
The company’s guidewires are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearance records. The portfolio is listed in the FDA’s 510(k) database, reflecting compliance with U.S. regulatory requirements. Ovalum, Ltd. is headquartered in the United States.
Catalogue
- 510(k) 510(k)
Frequently asked questions
How many devices does Ovalum, Ltd. have in the registry?
The registry currently lists 1 device for Ovalum, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ovalum, Ltd.'s devices?
Among its 1 most recently registered device, Ovalum, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Ovalum, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Ovalum, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ovalum, Ltd. in the registry?
The most recently registered devices listed for Ovalum, Ltd. include CITOP10 GUIDEWIRE, 0.014(1.4MM TIP), CITOP6 GUIDEWIRE, 0.014(1.0MM TIP), CITOP SUPPORT ACCESSORY, 0.023(126CM).