ALN OPTIONAL VANA CAVA FILTER— 510(k) K113124

Substantially Equivalent

Aln Implants Chirurgicaux

FDA 510(k) clearance K113124 for ALN OPTIONAL VANA CAVA FILTER, Substantially Equivalent on 2012-11-09. Applicant: Aln Implants Chirurgicaux.

Clearance details

Applicant: Aln Implants Chirurgicaux
Product code: Code DTK
Advisory panel: Cardiovascular
Date received: 2011-10-21
Decision date: 2012-11-09
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Jarnac, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code DTK

product code DTK

Death: 208
Injury: 11,286
Malfunction: 3,002
Total: 14,496

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.