Data / Medical devices / United States / Medinotec Inc
Medinotec Inc: FDA-registered device maker in Dix Hills, NY, United States, 1 510(k) clearance
Medinotec Inc is registered with the FDA (registration 3029663075) in Dix Hills, NY, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 11, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3029663075
- Address
- 200 Broadhollow Road, Dix Hills, NY, United States, 11747
- Owner or operator
- Medinotec Inc (10088772)
- Roles
- Repackager or relabeler
- First device listed
- March 14, 2025
- Registered through
- 2026
- Brand names listed
- OutFlo Aortic Valve Valvuloplasty Perfusion Dilatation Catheter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Balloon Aortic Valvuloplasty | OZT | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| March 11, 2025 | K241562 | OutFlo Aortic Valve Dilatation Balloon Catheter | OZT | Substantially Equivalent | Disa Medinotec | accessdata.fda.gov |
Compare with other makers
Updated March 11, 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.