K241507

Substantially Equivalent

ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK)

Applicant: Aln S.A.R.L.
Product code: DTK
Advisory panel: Cardiovascular
Date received: 2024-05-28
Decision date: 2024-06-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Bormes Les Mimosas, FR

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.