Data / Medical devices / Italy / Delta Med SpA
Delta Med SpA: FDA-registered device maker in Sorbolo Levante di Brescello Reggio Emilia, Italy, 2 510(k) clearances
Delta Med SpA is registered with the FDA (registration 3010754844) in Sorbolo Levante di Brescello Reggio Emilia, Italy. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated August 26, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010754844
- Address
- Street Emilio Gino Segre 6, Sorbolo Levante di Brescello Reggio Emilia, Italy, 42041
- Owner or operator
- Delta Med SpA (10056736)
- Roles
- Manufacturer
- First device listed
- January 10, 2018
- Registered through
- 2026
- Brand names listed
- Deltaven Closed I.V. Catheter Systems
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | 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 |
|---|---|---|---|---|---|---|
| August 26, 2020 | K200373 | Deltaven Fast Flash Closed I.V. Catheter Systems | FOZ | Substantially Equivalent | Delta Med Spa | accessdata.fda.gov |
| December 21, 2017 | K171530 | Deltaven XiV Max, Deltaven XiV Max FF | FOZ | Substantially Equivalent | Delta Med Spa | accessdata.fda.gov |
Compare with other makers
Updated August 26, 2020. 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.