Data / Medical devices / Turkey / Asset Medikal Tasarim San. Tic. A.S.
Asset Medikal Tasarim San. Tic. A.S.: FDA-registered device maker in istanbul, Turkey, 7 510(k) clearances
Asset Medikal Tasarim San. Tic. A.S. is registered with the FDA (registration 3015085713) in istanbul, Turkey. It lists 3 device types. The FDA files 7 510(k) clearances under its listings, the newest dated October 14, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015085713
- Address
- Ikitelli OSB Mahallesi, 17. Cadde, No:17, istanbul, Turkey, 34490
- Owner or operator
- ASSET MEDIKAL TASARIM SAN. TIC. A.S. (10063127)
- Roles
- Manufacturer
- First device listed
- March 17, 2020
- Registered through
- 2026
- Brand names listed
- AMSafe, DialySafe, FlowArt, Flowart, IMed Products, NeutrArt, Sol-Care, Sol-M and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Set, Administration, Intravascular | FPA | 2 | Manufacturer | accessdata.fda.gov |
| Set, I.V. Fluid Transfer | LHI | 2 | Manufacturer | accessdata.fda.gov |
| Stopcock, I.V. Set | FMG | 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 14, 2025 | K251715 | FlowArt® Vial Access Device Vented | LHI | Substantially Equivalent | Asset Medikal | accessdata.fda.gov |
| June 26, 2024 | K232987 | FlowArt Valve for Vial Access | LHI | Substantially Equivalent | Asset Medikal Tasarim Sanayi VE Ticaret A.S. | accessdata.fda.gov |
| January 20, 2023 | K222889 | FlowArt® Needle-Free Split Septum Valve | FPA | Substantially Equivalent | Asset Medikal Tasarim San Tic As. | accessdata.fda.gov |
| September 26, 2022 | K221473 | Flowart | FPA | Substantially Equivalent | Asset Medikal Tasarim As. | accessdata.fda.gov |
| September 23, 2022 | K221481 | NeutrArt | FPA | Substantially Equivalent | Asset Medikal Tasarim As. | accessdata.fda.gov |
| January 5, 2021 | K201872 | NeutrArt | FPA | Substantially Equivalent | Asset Medikal Tasarim As. | accessdata.fda.gov |
| February 20, 2020 | K190806 | Flowart | FPA | Substantially Equivalent | Asset Medikal Tasarim As. | accessdata.fda.gov |
Compare with other makers
- All makers of Set, I.V. Fluid Transfer
- All makers of Set, Administration, Intravascular
- All makers of Stopcock, I.V. Set
Updated October 14, 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.