# K151358: AZUR CX Detachable 35 Coils

- Pathway: 510(k) (Traditional)
- Applicant: MicroVention, Inc.
- Decided: Sep 25, 2015 after 128 days
- Product code: KRD (Device, Vascular, For Promoting Embolization)
- Device class: 2
- Regulation: 21 CFR 870.3300
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K951256 (1995). 59 ancestors in all.
No later device cites it as a predicate yet.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123384: Azur CX Detachable 18, MicroVention, Inc. (2012) Summary page 4.
- K130577: Azur Pushable 18 & 35 System, MicroVention, Inc. (2013) Summary page 4.

## Recalls of this device
- Aug 24, 2023 · Class II · Z-0187-2024: Peripheral coil system detachable has a potential of unsealed pouch packaging.
- Nov 24, 2019 · Class II · Z-1223-2020: The devices may be missing the implant coil.
- Nov 24, 2019 · Class II · Z-1224-2020: The devices may be missing the implant coil.
- Nov 24, 2019 · Class II · Z-1225-2020: The devices may be missing the implant coil.

## Indications for use
The AZUR Peripheral Coil 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/K151358
Methodology: https://510kreport.com/methodology