# K123384: Azur CX Detachable 18

- Pathway: 510(k) (Special)
- Applicant: MicroVention, Inc.
- Decided: Nov 28, 2012 after 26 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: 15 generations back to K951256 (1995). 56 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120630: Azur Detachable 18, MicroVention, Inc. (2012) Summary page 1.
- K071939: Hydrocoil Embolic Systems (Hes), MicroVention, Inc. (2008) Summary page 1.
- K100454: Hydrocoil Embolic System-Hydroframe Model 100931HFM-V, 101243HFM-V, 180827HFM-V, 181139HFM-V, 181445HFM-V, 181850HFM-V, MicroVention, Inc. (2010) Summary page 2.

## Most influential descendants
- K162524: AZUR CX Detachable 18 Peripheral Coil System (2017), 1 descendant of its own
- K223050: AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060) (2022), 0 descendants of its own
- 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 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/K123384
Methodology: https://510kreport.com/methodology