# K012145: Microplex Coil System

- Pathway: 510(k) (Traditional)
- Applicant: MicroVention, Inc.
- Decided: Oct 29, 2001 after 111 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: 5 generations back to K951256 (1995). 26 ancestors in all.
96 later devices descend from it; 4 cite it directly.
1 of 123 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002056: Micrus Microcoil Delivery System, MDS03, Micrus Corp. (2001) Summary page 2.
- K993417: GDC-10 Guglielmi Detachable Coil (GDC) (3D Shape GDC), GDC-18 Guglielmi Detachable Coil (GDC) (3D Shape GDC), Boston Scientific, Target (2000) Summary page 2.
- K991139: Guglielmi Detachable (GDC), Boston Scientific, Target (1999) Summary page 2.
- K951256: Detachable Platinum Coil (Guglielmi Detachable Coil, GDC), Target Therapeutics (1995) Summary page 2.

## Most influential descendants
- K020434: Microplex Coil System (MCS) (2002), 70 descendants of its own
- K032590: Microplex Coil System (MCS), Hydrocoil Embolic System (Hes) (2003), 68 descendants of its own
- K033836: Hydrocoil Embolic System (Hes) (2003), 67 descendants of its own
- K041551: Modification to: Hydrocoil Embolic System (Hes) (2004), 66 descendants of its own
- K050954: Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) (2005), 65 descendants of its own

## Indications for use
The MicroVention MicroPlex Coil System (MCS) is intended for endovascular 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/K012145
Methodology: https://510kreport.com/methodology