Del Mar Medical Systems, LLC
United StatesFDA applicant, unverified
- Devices
- 2
What Del Mar Medical Systems, LLC makes
Del Mar Medical Systems, LLC manufactures the ARIA, a cardiac ablation system designed for catheter-based treatment of arrhythmias, and the IMPRESARIO, a radiofrequency ablation generator used in electrophysiology procedures to modify heart tissue.
The company’s portfolio is regulated under FDA Class II devices, with products authorised via the 510(k) clearance pathway. These devices are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Aria Ref K001317
Regimes: 510(k) Registry: 510(k)Impresario Ref K993620
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Del Mar Medical Systems, LLC have in the registry?
The registry currently lists 2 devices for Del Mar Medical Systems, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Del Mar Medical Systems, LLC's devices?
Among its 2 most recently registered devices, Del Mar Medical Systems, LLC has devices listed in FDA 510(k) (2 devices).
What risk classes do Del Mar Medical Systems, LLC's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Del Mar Medical Systems, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Del Mar Medical Systems, LLC in the registry?
The most recently registered devices listed for Del Mar Medical Systems, LLC include ARIA and IMPRESARIO.