# K130577: Azur Pushable 18 & 35 System

- Pathway: 510(k) (Special)
- Applicant: MicroVention, Inc.
- Decided: Jun 17, 2013 after 104 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). 50 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071939: Hydrocoil Embolic Systems (Hes), MicroVention, Inc. (2008) Summary page 1.
- K091882: Azur Peripheral Hydrocoil Endovascular Embolization System, MicroVention, Inc. (2009) Summary page 1.
- K050954: Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes), MicroVention, Inc. (2005) Summary page 1.

## Most influential descendants
- K151358: AZUR CX Detachable 35 Coils (2015), 0 descendants of its own

## Indications for use
The AZUR System is intended to reduce or block the rate of blood flow 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/K130577
Methodology: https://510kreport.com/methodology