# K022735: Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) with the Hydrolink Syringe Kit

- Pathway: 510(k) (Special)
- Applicant: MicroVention, Inc.
- Decided: Sep 6, 2002 after 18 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: 7 generations back to K951256 (1995). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 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.
- K021914: Microplex Coil Systems (MCS), MicroVention, Inc. (2002) Summary page 2.
- K020434: Microplex Coil System (MCS), MicroVention, Inc. (2002) Summary page 2.
- K875196: Disposable Coronary Control Syringe 12CC, Merit Medical Systems, Inc. (1988) Summary page 2.

## Indications for use
The MicroPlex Coil System (MCS) and Hydrocoil Embolic System (HES) with the HydroLink Syringe Kit are 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. The MCS and HES are also intended for embolization of other neuro-vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae and for arterial and venous embolizations in the peripheral vasculature.

Source page: https://510kreport.com/device/K022735
Methodology: https://510kreport.com/methodology