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

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

510(k) Number

K241507 ↗

FDA Product Code

DTK

Device Class

Class II

Regulation

21 CFR Part 870.3375

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• What are the key differences between the ALN Optional Vena Cava Filter models with and without hooks, and how might this affect clinical decision-making?

  The ALN Optional Vena Cava Filter is available in versions with and without hooks (FB.HOOK, FF.HOOK, FJ.HOOK vs. FB.010500, FF.010995, FJ.120096). Hooks may improve fixation within the vena cava, potentially reducing migration risk, which could be relevant for patients with anatomical challenges or higher embolism recurrence risk. Clinicians may choose hook versions for cases requiring enhanced stability, while non-hook versions may suffice for standard placements. The decision depends on patient-specific factors like vascular anatomy and clinical history.

• Is the ALN Optional Vena Cava Filter intended for reuse, or is it strictly single-use? How should it be handled to ensure safety?

  The ALN Optional Vena Cava Filter is explicitly designed for single-use only, as stated in the device description. Since it is not sterilized for reuse and must be handled under aseptic conditions, it should be considered a sterile, one-time-use device. Proper sterile packaging and adherence to clinical aseptic techniques during deployment are critical to prevent infection or contamination.

• What regulatory pathways has the ALN Optional Vena Cava Filter followed, and what does this mean for its use in clinical practice?

  The device has undergone FDA 510(k) clearance (K241507) and MDR authorization, confirming its compliance with U.S. and EU regulatory standards. The classification as a Class II device under FDA regulations indicates it is subject to special controls, including performance standards and post-market surveillance. Clinicians can rely on this regulatory history to ensure the device meets established safety and effectiveness criteria for preventing recurrent pulmonary embolism in patients where anticoagulants are ineffective or contraindicated.

• Are there specific storage requirements for the ALN Optional Vena Cava Filter, or can it be stored under standard operating room conditions?

  The provided data does not specify sterilization status or storage conditions beyond standard aseptic handling. While the device is not explicitly labeled as sterile, it must be treated as such in clinical settings to prevent infection. Storage should follow manufacturer guidelines (if available) or standard practices for intravascular devices—typically in a clean, dry environment protected from contamination until immediate use. Always verify the packaging integrity before deployment.