Data / Medical devices / France / Aln S.A.R.L.
Aln S.A.R.L.: FDA-registered device maker in BORMES LES MIMOSAS Var, France, 2 510(k) clearances
Aln S.A.R.L. is registered with the FDA (registration 3007080617) in BORMES LES MIMOSAS Var, France. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated June 26, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007080617
- Address
- 589 Chemin Du Niel, BORMES LES MIMOSAS Var, France, 83230
- Owner or operator
- ALN S.A.R.L. (10026909)
- Roles
- Manufacturer
- First device listed
- October 18, 2017
- Registered through
- 2026
- Brand names listed
- ALN Extraction and/or Repositioning Kit- 2 in 1 RS, ALN Extraction and/or Repositioning Kit- Pre-curved RS, ALN Extraction and/or Repositioning Kit- Straight RS, ALN Optional Vena Cava Filter - Brachial Approach (FB10500), ALN Optional Vena Cava Filter - Brachial Approach with Hook (FB.HOOK), ALN Optional Vena Cava Filter - Femoral Approach (FF10995), ALN Optional Vena Cava Filter - Femoral Approach with Hook (FF.HOOK), ALN Optional Vena Cava Filter - Jugular Approach (FJ.120096) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Filter, Intravascular, Cardiovascular | DTK | 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 |
|---|---|---|---|---|---|---|
| June 26, 2024 | K241507 | ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK) | DTK | Substantially Equivalent | Aln S.A.R.L. | accessdata.fda.gov |
| September 8, 2017 | K163699 | ALN Optional Vena Cava Filter - Femoral Approach, ALN Optional Vena Cava Filter - Jugular Approach, ALN Optional Vena Cava Filter - Brachial Approach, ALN Optional Vena Cava Filter - Femoral Approach with Hook | DTK | Substantially Equivalent | Aln Implants Chirurgicaux | accessdata.fda.gov |
Compare with other makers
Updated June 26, 2024. 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.