# K070514: Aln Optional Vena Cava Filter-Femoral Approach, Jugular Approach, Brachial Approach, Extraction Kit, Precurved Extractio

- Pathway: 510(k) (Abbreviated)
- Applicant: Aln Implants Chirurgicaux
- Decided: Jan 30, 2008 after 342 days
- Product code: DTK (Filter, Intravascular, Cardiovascular)
- Device class: 2
- Regulation: 21 CFR 870.3375
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K912035 (1995). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912035: Stainless Steel Green Vena Cava Filt W/12F Intr SY, Boston Scientific Corp (1995) Summary page 2.
- K031328: Recovery Filter System, Model RF-048F, C.R. Bard, Inc. (2003) Summary page 2.

## Most influential descendants
- K113124: Aln Optional Vana Cava Filter (2012), 0 descendants of its own

## Indications for use
The ALN Optional Vena Cava Filter is indicated for the prevention of recurrent pulmonary embolism via placement in the vena cava in the following situations: - Pulmonary thromboembolism when anticoagulants are contraindicated; - Failure of anticoagulant therapy in thromboembolic diseases; - Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced; and - Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated. The ALN Optional Vena Cava Filter may be retrieved according to the instructions supplied in the Instruction For Use of the ALN Extraction Kit. Extraction kit: The ALN Optional Vena Cava Filter Extraction Kit has been designed for the removal of an implanted ALN Optional Vena Cava Filter in patients who no longer require a filter. The retrieval of the filter can be performed only by jugular approach.

Source page: https://510kreport.com/device/K070514
Methodology: https://510kreport.com/methodology