# K132083: Azur Pure Peripheral Coil Systems, Pushable 35

- Pathway: 510(k) (Traditional)
- Applicant: MicroVention, Inc.
- Decided: Oct 28, 2013 after 115 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). Our reading of the summary gave K112543, FDA’s number for Wallflex Biliary Transhepatic Uncovered Stent System… (Boston Scientific Corporation). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “AZUR PURE Peripheral Coil System, Pushable 35”. 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/K132083
Methodology: https://510kreport.com/methodology