# K122316: Azur Detachable 35

- Pathway: 510(k) (Special)
- Applicant: MicroVention, Inc.
- Decided: Aug 29, 2012 after 28 days
- Product code: KRD (Device, Vascular, For Promoting Embolization)
- Device class: 2
- Regulation: 21 CFR 870.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K951256 (1995). 51 ancestors in all.
No later device cites it as a predicate yet.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093002: Azur Peripheral Hydrocoil Endovascular Embolization System-Detachable 35, Models 45-450405, 45-450410, 45-450610, MicroVention, Inc. (2009) Summary page 1.

## Indications for use
The AZUR System is intended to reduce or block the rate of bloodflow in vessels of the peripheral vasculature. It is intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms, and other lesions of the peripheral vasculature.

Source page: https://510kreport.com/device/K122316
Methodology: https://510kreport.com/methodology