# K021914: Microplex Coil Systems (MCS)

- Pathway: 510(k) (Special)
- Applicant: MicroVention, Inc.
- Decided: Jul 9, 2002 after 28 days
- Product code: HCG (Device, Neurovascular Embolization)
- Device class: 2
- Regulation: 21 CFR 882.5950
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K951256 (1995). 27 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012145: Microplex Coil System, MicroVention, Inc. (2001) Summary page 2.

## Most influential descendants
- K022735: Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) with the Hydrolink Syringe Kit (2002), 0 descendants of its own

## Indications for use
The MicroPlex Coil System (MCS) is intended for embolization of those intracranial aneurysms that - because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team to be very high risk for management by traditional operative techniques or inoperable.

Source page: https://510kreport.com/device/K021914
Methodology: https://510kreport.com/methodology