# K102365: Microplex Coil System- Cosmos

- Pathway: 510(k) (Traditional)
- Applicant: MicroVention, Inc.
- Decided: Nov 18, 2010 after 90 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). 45 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093358: Microplex Coil System-Cosmos, Models 81451CS-V, 181555CS-V, 16=81652CS-V, MicroVention, Inc. (2010) Summary page 1.
- K090891: Microplex Coil System-Cosmos, MicroVention, Inc. (2009) Summary page 1.

## Most influential descendants
- K132952: Microplex Coil System (MCS), Hydrocoil Embolic System (Hes) (2013), 2 descendants of its own
- K153594: MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES) (2016), 1 descendant of its own
- K161452: MicroPlex Coil System (MCS) - HyperSoft 3D (2016), 0 descendants of its own

## Indications for use
The MicroPlex Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The MCS is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct bloodflow, to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.

Source page: https://510kreport.com/device/K102365
Methodology: https://510kreport.com/methodology