# K120630: Azur Detachable 18

- Pathway: 510(k) (Special)
- Applicant: MicroVention, Inc.
- Decided: Mar 28, 2012 after 27 days
- Product code: KRD (Device, Vascular, For Promoting Embolization)
- Device class: 2
- Regulation: 21 CFR 870.3300
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K951256 (1995). 50 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090168: Azur Detactable 18, Models 45-480305, 45-480310, 45-480405, 44-480415, MicroVention, Inc. (2009) Summary page 1.
- K071939: Hydrocoil Embolic Systems (Hes), MicroVention, Inc. (2008) Summary page 1.

## Most influential descendants
- K123384: Azur CX Detachable 18 (2012), 3 descendants of its own
- 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

## Recalls of this device
- Nov 24, 2019 · Class II · Z-1220-2020: The devices may be missing the implant coil.
- Nov 24, 2019 · Class II · Z-1221-2020: The devices may be missing the implant coil.
- Nov 24, 2019 · Class II · Z-1222-2020: The devices may be missing the implant coil.

## 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 fisulae, aneurysms, and other lesions of the peripheral vasculature.

Source page: https://510kreport.com/device/K120630
Methodology: https://510kreport.com/methodology