# K133626: Azur Pure Peripheral Coil System, Pushable 35

- Pathway: 510(k) (Special)
- Applicant: MicroVention, Inc.
- Decided: Dec 20, 2013 after 24 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: 14 generations back to K951256 (1995). 51 ancestors in all.
No later device cites it as a predicate yet.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122543: Azur Pure Peripheral Coil System, Pushable 18 Azur Pure Peripheral Coil System, Pushable 35, MicroVention, Inc. (2012) Summary page 1.

## Indications for use
The AZUR PURE 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/K133626
Methodology: https://510kreport.com/methodology