# K223050: AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)

- Pathway: 510(k) (Traditional)
- Applicant: MicroVention, Inc.
- Decided: Dec 21, 2022 after 83 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: 17 generations back to K951256 (1995). 58 ancestors in all.
No later device cites it as a predicate yet.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162524: AZUR CX Detachable 18 Peripheral Coil System, MicroVention, Inc. (2017) Summary page 4.
- K123384: Azur CX Detachable 18, MicroVention, Inc. (2012) Summary page 4.

## 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/K223050
Methodology: https://510kreport.com/methodology