# K093002: Azur Peripheral Hydrocoil Endovascular Embolization System-Detachable 35, Models 45-450405, 45-450410, 45-450610

- Pathway: 510(k) (Special)
- Applicant: MicroVention, Inc.
- Decided: Oct 28, 2009 after 30 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: 12 generations back to K951256 (1995). 50 ancestors in all.
12 later devices descend from it; 2 cite it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K123803: Reverse Medical Micro Vascular Plug (MVP) System (2013), 10 descendants of its own
- K133282: Reverse Medical Micro Vascular Plug (MVP) System (2013), 6 descendants of its own
- K141313: Reverse Medical Micro Vascular Plug System (2014), 5 descendants of its own
- K150108: Reverse Medical Micro Vascular Plug System (2015), 4 descendants of its own
- K133924: Endoluminal Occlusion System (Eos) (2014), 2 descendants of its own

## Indications for use
The Azur PeripheralHydroCoilEndovascularEmbolization Coil System is intended to reduce or block the rate of bloodflow in vessels of the peripheralvasculature. It is intendedfor use in the interventionalradiologicmanagement of arteriovenous malformations, arteriovenousfistulae,aneurysms, and other lesions of the peripheral vasculature.

Source page: https://510kreport.com/device/K093002
Methodology: https://510kreport.com/methodology