# K113124: Aln Optional Vana Cava Filter

- Pathway: 510(k) (Abbreviated)
- Applicant: Aln Implants Chirurgicaux
- Decided: Nov 9, 2012 after 385 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: 2 generations back to K912035 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 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.
- K090140: Gunther Tulip Vena Cava Filter, Cook Celect Vena Cava Filter, William Cook Europe Aps (2009) Summary page 2.
- K070514: Aln Optional Vena Cava Filter-Femoral Approach, Jugular Approach, Brachial Approach, Extraction Kit, Precurved Extractio, Aln Implants Chirurgicaux (2008) Summary page 3.

## Indications for use
The ALN Optional Vena Cava Filter and the ALN Optional Vena Cava Filter wit Hook 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 and the ALN Optional Vena Cava Filter with Hook may be retrieved according to the instructions supplied in the Instruction For Use of the ALN Extraction Kit. The ALN Optional Vena Cava Filter with Hook may be retrieved with a standard GooseNeck Snare according to the instructions supplied in the Instruction For Use of this medical device. Extraction kit: The AIN Optional Vena Cava Filter Extraction Kit has been designed for the removal of an implanted ALN Optional Vena Cava Filter or ALN Optional Vena Cava Filter with Hook 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/K113124
Methodology: https://510kreport.com/methodology