Coils
Azur
A non-bioabsorbable, implantable device intended to induce a thrombosis within a non-neurovascular blood vessel to treat an aneurysm and/or non-neurovascular arteriovenous malformation (AVM); it is not intended for neurovascular application. It is in the form of a metal or metal/synthetic polymer wire which coils upon deployment within an aneurysm or the vasculature surrounding a malformation; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included.
Azur models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| 45-480202-02 | — | MR Conditional | Available |
| 45-480204-02 | — | MR Conditional | Available |
| 45-480302-02 | — | MR Conditional | Available |
| 45-480305-02 | — | MR Conditional | Available |
| 45-480310-02 | — | MR Conditional | Available |
| 45-480405-02 | — | MR Conditional | Available |
| 45-480410-02 | — | MR Conditional | Available |
| 45-480415-02 | — | MR Conditional | Available |
| 45-480420-02 | — | MR Conditional | Available |
| 45-480505-02 | — | MR Conditional | Available |
| 45-480510-02 | — | MR Conditional | Available |
| 45-480515-02 | — | MR Conditional | Available |
| 45-480520-02 | — | MR Conditional | Available |
| 45-480610-02 | — | MR Conditional | Available |
| 45-480615-02 | — | MR Conditional | Available |
| 45-480620-02 | — | MR Conditional | Available |
| 45-480810-02 | — | MR Conditional | Available |
| 45-480815-02 | — | MR Conditional | Available |
| 45-480820-02 | — | MR Conditional | Available |
| 45-481010-02 | — | MR Conditional | Available |
| 45-481015-02 | — | MR Conditional | Available |
| 45-481020-02 | — | MR Conditional | Available |
| 45-481215-02 | — | MR Conditional | Available |
| 45-481220-02 | — | MR Conditional | Available |
| 45-481515-02 | — | MR Conditional | Available |
| 45-481520-02 | — | MR Conditional | Available |
| 45-481530-02 | — | MR Conditional | Available |
| 45-482020-02 | — | MR Conditional | Available |
| 45-482030-02 | — | MR Conditional | Available |
| 45-680820-02 | — | MR Conditional | Available |
| 45-681026-02 | — | MR Conditional | Available |
| 45-681434-02 | — | MR Conditional | Available |
| 45-682050-02 | — | MR Conditional | Available |
| 45-780202-02 | — | MR Conditional | Available |
| 45-780202-L | — | MR Conditional | Available |
| 45-780204-02 | — | MR Conditional | Available |
| 45-780204-L | — | MR Conditional | Available |
| 45-780304-02 | — | MR Conditional | Available |
| 45-780304-L | — | MR Conditional | Available |
| 45-780308-02 | — | MR Conditional | Available |
| 45-780308-L | — | MR Conditional | Available |
| 45-780413-02 | — | MR Conditional | Available |
| 45-780516-02 | — | MR Conditional | Available |
| 45-780620-02 | — | MR Conditional | Available |
| 45-780724-02 | — | MR Conditional | Available |
| 45-780828-02 | — | MR Conditional | Available |
| 45-780928-02 | — | MR Conditional | Available |
| 45-781032-02 | — | MR Conditional | Available |
| 45-781238-02 | — | MR Conditional | Available |
| 45-781434-02 | — | MR Conditional | Available |
| 45-781639-02 | — | MR Conditional | Available |
| 45-781836-02 | — | MR Conditional | Available |
| 45-782040-02 | — | MR Conditional | Available |
| 45-880005 | — | MR Conditional | Available |
| 45-880010 | — | MR Conditional | Available |
| 45-880020 | — | MR Conditional | Available |
| 45-880035 | — | MR Conditional | Available |
| 45-880050 | — | MR Conditional | Available |
| 45-880060 | — | MR Conditional | Available |
FDA clearances
- 510(k) K223050 December 2022
Procedures that use coils
Frequently asked questions
What is Azur used for?
A non-bioabsorbable, implantable device intended to induce a thrombosis within a non-neurovascular blood vessel to treat an aneurysm and/or non-neurovascular arteriovenous malformation (AVM); it is not intended for neurovascular application. It is in the form of a metal or metal/synthetic polymer wire which coils upon deployment within an aneurysm or the vasculature surrounding a malformation; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included.
Who makes Azur?
Azur is made by Microvention, Inc.. It is listed under embolization coils in our device library.
What sizes does Azur come in?
The FDA device database does not list sizes for Azur. Check the instructions for use or ask a Microvention, Inc. representative.
Is Azur MRI safe?
The FDA device database lists Azur as MR Conditional. Always follow the specific MRI conditions in the labeling.
Is Azur FDA cleared?
Azur is covered by FDA submission K223050.
How do I contact a Microvention, Inc. sales representative?
Microvention, Inc. has not listed representatives on LA Vascular yet. Visit the Microvention, Inc. company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.