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

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K070514 ↗

FDA Product Code

DTK

Device Class

Class II

Regulation

21 CFR Part 870.3375

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• 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

  Class II

  CE/MDR FDA 510(k) K163699 Active Cleared 8 Sep 2017

• Aln Optional Vana Cava Filter

  Class II

  FDA 510(k) K113124 Active Cleared 9 Nov 2012

• What are the key approaches for placing the ALN Optional Vena Cava Filter, and how does this affect its versatility in clinical settings?

  The ALN Optional Vena Cava Filter is designed for placement via three venous access routes: femoral, jugular, or brachial approaches. This multi-approach capability enhances its versatility, allowing clinicians to choose the most suitable method based on patient anatomy, procedural needs, or emergency circumstances. For example, femoral access may be preferred for stability, while jugular or brachial approaches could be advantageous in cases where lower limb access is compromised.

• Is the ALN Optional Vena Cava Filter compatible with MRI scans, and why might this be important for patients?

  Yes, the ALN Optional Vena Cava Filter is explicitly designed to be MRI-compatible. This is important because it allows patients to undergo MRI imaging without the risk of device-related complications, such as heating or displacement, which could occur with non-MRI-safe implants. This feature is particularly valuable for long-term monitoring or follow-up of patients with suspected or confirmed pulmonary embolism risk.

• What sizes of the ALN Optional Vena Cava Filter are available, and how does this accommodate different patient anatomies?

  The ALN Optional Vena Cava Filter is available in sizes suitable for vena cava diameters up to 32 mm. This range ensures compatibility with a broad spectrum of patient anatomies, allowing clinicians to select the appropriate size for optimal placement and function. The sizing flexibility reduces the risk of improper fit, which could lead to ineffective thrombus capture or device migration.

• How should the ALN Optional Vena Cava Filter be stored, and what precautions should be taken to maintain its integrity?

  The device must be stored in a way that protects it from moisture and mechanical damage, as specified by the manufacturer. This includes keeping it in its original packaging until ready for use and ensuring it is stored in a clean, dry environment. Proper storage is critical to preserve sterility and structural integrity, as any compromise could affect its performance or safety during implantation.

• Is the ALN Optional Vena Cava Filter intended for single-use only, and what does this mean for clinical workflows?

  Yes, the ALN Optional Vena Cava Filter is supplied as a sterile, single-use kit. This design ensures patient safety by eliminating the risk of cross-contamination or device degradation from reuse. Clinically, this means each procedure requires a new kit, which may impact inventory management and workflow planning, particularly in high-volume settings where multiple placements or retrievals are anticipated.