Data / Medical devices / United States / Basis Medical
Basis Medical: FDA-registered device maker in Miami, FL, United States, 1 510(k) clearance
Basis Medical is registered with the FDA (registration 3038912532) in Miami, FL, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated February 28, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3038912532
- Address
- 2916 N Miami Ave, Ste 621, Miami, FL, United States, 33127
- Owner or operator
- Basis Medical LLC (10093639)
- Roles
- Specification developer
- First device listed
- June 16, 2025
- Registered through
- 2026
- Brand names listed
- Basis Medical Seclusion Catheter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Percutaneous | DQY | 2 | 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 |
|---|---|---|---|---|---|---|
| February 28, 2025 | K243436 | Seclusion Catheter | DQY | Substantially Equivalent | Basis Medical | accessdata.fda.gov |
Compare with other makers
Updated February 28, 2025. 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.