The following data is part of a premarket notification filed by Aln Implants Chirurgicaux with the FDA for 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.
| Device ID | K163699 |
| 510k Number | K163699 |
| Device Name: | 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 |
| Classification | Filter, Intravascular, Cardiovascular |
| Applicant | ALN Implants Chirurgicaux 589 Chemin Du Niel Bormes Les Mimosas, FR 83230 |
| Contact | Alain Nigon |
| Correspondent | Jagoda Rewers ALN Implants Chirurgicaux 589 Chemin Du Niel Bormes Les Mimosas, FR 83230 |
| Product Code | DTK |
| CFR Regulation Number | 870.3375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-29 |
| Decision Date | 2017-09-08 |
| Summary: | summary |