Skip to content

Wallaby Avenir Coil System

by Wallaby Medical, Inc. EUDAMED510(k)

Active European Union and United States

510(k) K173711Ref 10CFS06010Model 10USC01001

Overview

The Wallaby Avenir Coil System is a neurovascular embolization device designed for occluding blood vessels. It consists of platinum/tungsten embolization coils delivered via a microcatheter, intended for use in both neurovascular and peripheral embolization procedures. These coils are structured with complex framing, helical filling, and finishing components to ensure reliable deployment and detachment within the vascular lumen.

The system is supplied as a sterile, single-use device and is intended for use in interventional radiology and neurosurgery settings. It is classified as a Class II medical device under FDA regulations (882.5950) and has received FDA 510(k) clearance (K173711) and MDR authorization. Coils are available in multiple reference codes for various vessel sizes, ensuring compatibility with different clinical applications. Storage and handling follow standard sterile medical device protocols.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberMDR 807342 Date20 Aug 2026IssuedStatusActive expires 22 Jul 2030
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK173711 Date4 May 2018ClearedStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 807342 Supplemented

    Technical documentation EU MDR

    Notified body
    Notified body 2797
    Issued
    20 Aug 2026
    Expires
    22 Jul 2030
    Reason
    Change approved

Specification

EUDAMED · 510(k)

Trade Name
Avenir Coil System
Model / Reference
10USC01001, 10CFS06010
Primary DI / UDI-DI
06970908217470
Basic UDI-DI
0697090821WCS0013H9
Direct Marketing DI
06970908217470
510(k) Number
FDA Product Code
HCG
EMDN Code
Z12109001 Detachable coil equipment for brain aneurysms
Device Class
Class III EUDAMED
Class II 510(k)
Regulation
21 CFR Part 882.5950
Market of Registration
Germany
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Truth per registry

2 sources · 1 field differs

FieldEUDAMED510(k)
Device ClassEUDAMED
Class III
510(k)
Class II

Other devices from Wallaby Medical

See all devices from Wallaby Medical →

Questions

  • What is the Wallaby Avenir Coil System used for?

    The Wallaby Avenir Coil System is designed specifically for occluding blood vessels during embolization procedures. Its platinum/tungsten construction and complex coil structure ensure stable deployment and detachment within the vascular lumen, making it suitable for both neurovascular and peripheral embolization in interventional radiology and neurosurgery settings.

  • How is the Wallaby Avenir Coil System supplied?

    The system is supplied as a sterile, single-use device. This ensures patient safety by preventing cross-contamination and maintains the integrity of the coils for a single procedure, adhering to standard sterile medical device protocols.

  • Are the coils reusable or intended for single-use?

    The Wallaby Avenir Coil System is explicitly designed for single-use only. This aligns with best practices for sterile medical devices to minimize infection risks and ensure consistent performance during embolization procedures.

  • What vessel sizes are compatible with the Wallaby Avenir Coil System?

    The system offers multiple reference codes for coils, each tailored to different vessel sizes. This variety ensures compatibility with a wide range of clinical applications, from neurovascular to peripheral embolization, allowing clinicians to select the appropriate coil for their specific case.

  • How should the Wallaby Avenir Coil System be stored?

    Storage follows standard sterile medical device protocols. The coils should be kept in their original packaging until ready for use, protected from contamination, moisture, and physical damage. Proper storage ensures the device remains sterile and functional for its intended single-use application.

Properties

  • Sterile
  • Implantable

Other properties (11)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No