Data / Medical devices / United States / Eosolutions, Corp.
Eosolutions, Corp.: FDA-registered device maker in Miramar, FL, United States, 2 510(k) clearances
Eosolutions, Corp. is registered with the FDA (registration 3025028711) in Miramar, FL, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 27, 2023. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3025028711
- Address
- 10370 USA Today Way, Miramar, FL, United States, 33025
- Owner or operator
- EOSolutions, Corp. (10086469)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- November 11, 2022
- Registered through
- 2026
- Brand names listed
- Banner Balloon Guide Catheter, Thinline Sheath
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Percutaneous | DQY | 2 | Specification developer | accessdata.fda.gov |
| Catheter, Percutaneous, Neurovasculature | QJP | 2 | Specification developer | accessdata.fda.gov |
| Introducer, Catheter | DYB | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 27, 2023 | K232260 | Thinline Sheath Introducer | DYB | Substantially Equivalent | Inneuroco, Inc. | accessdata.fda.gov |
| July 29, 2022 | K220331 | 091 Balloon Guide Catheter | DQY | Substantially Equivalent | Inneuroco, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Introducer, Catheter
- All makers of Catheter, Percutaneous, Neurovasculature
- All makers of Catheter, Percutaneous
Updated September 27, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.