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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

by Aln Implants Chirurgicaux

510(k) K163699

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K163699↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Abbreviated NumberK163699 Date8 Sep 2017ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
DTK
Device Class
Class II
Regulation
21 CFR Part 870.3375
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The ALN Optional Vena Cava Filter is a retrievable intravascular device designed to prevent pulmonary embolism by capturing thrombi within the inferior vena cava. Classified as an Intravascular Filter under the Cardiovascular category, it is intended for placement via femoral, jugular, or brachial venous access, including a variant with a hook for enhanced fixation. The device conforms to the regulatory definition of a filter intended for temporary or permanent use in venous circulation.

These filters are supplied sterile and intended for single-use, with retrieval capabilities to allow removal once venous thrombosis risk is resolved. They are manufactured in multiple configurations to accommodate different vascular access points and are regulated under FDA 510(k) clearance and EU MDR compliance. Storage requires adherence to sterile packaging instructions, and sizing is determined by the patient’s venous anatomy. The device carries registration numbers and product codes for traceability in regulatory databases.

Other devices from Aln Implants Chirurgicaux

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What are the key differences between the ALN Optional Vena Cava Filter variants, and how do they affect placement options?

    The ALN Optional Vena Cava Filter comes in four variants: Femoral Approach, Jugular Approach, Brachial Approach, and Femoral Approach with Hook. The first three are designed for placement via their respective venous access points, while the Femoral Approach with Hook includes an additional fixation mechanism to improve stability during retrieval or prolonged use. This makes the hook variant particularly useful for patients requiring extended filter retention or those with higher risk of migration.

  • Is the ALN Optional Vena Cava Filter intended for temporary or permanent use, and how does retrieval work?

    The ALN Optional Vena Cava Filter is explicitly designed for temporary or permanent use in the venous circulation, with retrieval capabilities to allow removal once the venous thrombosis risk is resolved. This dual-purpose design provides flexibility for clinicians to either leave the filter in place long-term or remove it when no longer needed, reducing unnecessary exposure to the device.

  • How should the ALN Optional Vena Cava Filter be stored, and what considerations should be made for its single-use nature?

    The device is supplied sterile and intended for single-use only, so storage must strictly follow the manufacturer’s sterile packaging instructions to maintain integrity. Since it cannot be reused, proper inventory management is critical to ensure availability when needed, and any opened or exposed packaging should be discarded to prevent contamination or cross-use risks.

  • What regulatory pathways does the ALN Optional Vena Cava Filter follow, and how does this impact traceability?

    The ALN Optional Vena Cava Filter is regulated under FDA 510(k) clearance (K163699) and EU MDR compliance, ensuring adherence to both U.S. and European medical device standards. Each variant carries unique registration numbers and product codes (e.g., DTK) for traceability in regulatory databases, which helps with post-market surveillance, recalls, and compliance audits. These identifiers are essential for tracking device performance and patient outcomes.

  • How is sizing determined for the ALN Optional Vena Cava Filter, and does it accommodate different patient anatomies?

    Sizing for the ALN Optional Vena Cava Filter is based on the patient’s venous anatomy, particularly the diameter of the inferior vena cava. While exact sizing details aren’t specified in the data, the device is manufactured in multiple configurations to ensure compatibility with femoral, jugular, and brachial access routes. Clinicians should use imaging (e.g., venography) to select the appropriate size for optimal placement and function, minimizing risks like filter migration or occlusion.