Dimesol, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Dimesol, Inc. makes
Dimesol, Inc. manufactures disposable arteriovenous (AV) fistula needle sets, including both non-safety and safety series variants, designed for vascular access procedures. The company also produces tubing sets specifically for hemodialysis applications, intended for use in renal treatment circuits.
The portfolio consists of Class II medical devices, regulated under the FDA’s 510(k) clearance pathway. These products are listed in the FDA’s 510(k) database, reflecting their authorised status for commercial distribution in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Dimesol Tubing Sets for Hemodialysis Ref K171952
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Dimesol, Inc. have in the registry?
The registry currently lists 2 devices for Dimesol, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dimesol, Inc.'s devices?
Among its 2 most recently registered devices, Dimesol, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Dimesol, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Dimesol, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Dimesol, Inc. in the registry?
The most recently registered devices listed for Dimesol, Inc. include Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series) and Dimesol Tubing Sets for Hemodialysis.