The following data is part of a premarket notification filed by Aln Implants Chirurgicaux with the FDA for Aln Optional Vana Cava Filter.
Device ID | K113124 |
510k Number | K113124 |
Device Name: | ALN OPTIONAL VANA CAVA FILTER |
Classification | Filter, Intravascular, Cardiovascular |
Applicant | ALN IMPLANTS CHIRURGICAUX 2 RUE QUENOT Jarnac, FR 16200 |
Contact | Cynthia Cottereau |
Correspondent | Cynthia Cottereau ALN IMPLANTS CHIRURGICAUX 2 RUE QUENOT Jarnac, FR 16200 |
Product Code | DTK |
CFR Regulation Number | 870.3375 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-10-21 |
Decision Date | 2012-11-09 |
Summary: | summary |