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, Jugular Approach, Brachial Approach, Extraction Kit, Precurved Extractio.
| Device ID | K070514 |
| 510k Number | K070514 |
| Device Name: | ALN OPTIONAL VENA CAVA FILTER-FEMORAL APPROACH, JUGULAR APPROACH, BRACHIAL APPROACH, EXTRACTION KIT, PRECURVED EXTRACTIO |
| Classification | Filter, Intravascular, Cardiovascular |
| Applicant | ALN IMPLANTS CHIRURGICAUX 900 CIRCLE 75 PKWY. SUITE 1240 Atlanta, GA 30339 |
| Contact | Dave Parente |
| Correspondent | Dave Parente ALN IMPLANTS CHIRURGICAUX 900 CIRCLE 75 PKWY. SUITE 1240 Atlanta, GA 30339 |
| Product Code | DTK |
| CFR Regulation Number | 870.3375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-22 |
| Decision Date | 2008-01-30 |
| Summary: | summary |