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— 510(k) K163699

Substantially Equivalent

Aln Implants Chirurgicaux

FDA 510(k) clearance K163699 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, Substantially Equivalent on 2017-09-08. Applicant: Aln Implants Chirurgicaux.

Clearance details

Applicant: Aln Implants Chirurgicaux
Product code: Code DTK
Advisory panel: Cardiovascular
Date received: 2016-12-29
Decision date: 2017-09-08
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Bormes Les Mimosas, FR

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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.