Data / Medical devices / Greece / Rontis Hellas S.A.
Rontis Hellas S.A.: FDA-registered device maker in Larisa Thessalia, Greece, 1 510(k) clearance
Rontis Hellas S.A. is registered with the FDA (registration 3011142981) in Larisa Thessalia, Greece. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 24, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011142981
- Address
- Industrial Area of Larisa, Larisa Thessalia, Greece, 41500
- Owner or operator
- Rontis Hellas SA (10050943)
- Roles
- Manufacturer
- First device listed
- November 6, 2019
- Registered through
- 2026
- Brand names listed
- Cronus
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Angioplasty, Peripheral, Transluminal | LIT | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Percutaneous | DQY | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| October 24, 2019 | K190037 | Cronus HP PTA Balloon Catheter | LIT | Substantially Equivalent | Nipro Medical Corporation | accessdata.fda.gov |
Compare with other makers
Updated October 24, 2019. 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.