# K132952: Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)

- Pathway: 510(k) (Special)
- Applicant: MicroVention, Inc.
- Decided: Dec 19, 2013 after 91 days
- Product code: HCG (Device, Neurovascular Embolization)
- Device class: 2
- Regulation: 21 CFR 882.5950
- Recalls of this device: 16 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K951256 (1995). 57 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103758: Microplex Coil System- Cosmos 10, Hydrocoil System- Hydroframe 10, MicroVention, Inc. (2011) Summary page 1.
- K091641: Hydrocoil Embolic System (Hydrosoft) and Microplex Coil System (Hypersoft), MicroVention, Inc. (2009) Summary page 1.
- K111451: Microplex Coil System-Vector Model 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V, 061030XXX-V, 101530XXX-V, 101540XX, MicroVention, Inc. (2011) Summary page 1.
- K093919: Microplex Coil System-Cosmos Model 100933CSSR-V, 101036CSSR-V, 101141CSSR-V, 101245CSSR-V, MicroVention, Inc. (2010) Summary page 1.
- K090891: Microplex Coil System-Cosmos, MicroVention, Inc. (2009) Summary page 1.
- K093358: Microplex Coil System-Cosmos, Models 81451CS-V, 181555CS-V, 16=81652CS-V, MicroVention, Inc. (2010) Summary page 1.
- K102365: Microplex Coil System- Cosmos, MicroVention, Inc. (2010) Summary page 1.
- K113457: Hydrocoil Embolic System (Hes), MicroVention, Inc. (2011) Summary page 1.
- K112226: Hydrocoil Embolic System (Hes), MicroVention, Inc. (2011) Summary page 1.
- K120908: Hydrocoil Embolic System (Hes), MicroVention, Inc. (2012) Summary page 1.
- K090357: Hydroframe (Hes), MicroVention, Inc. (2009) Summary page 1.
- K100454: Hydrocoil Embolic System-Hydroframe Model 100931HFM-V, 101243HFM-V, 180827HFM-V, 181139HFM-V, 181445HFM-V, 181850HFM-V, MicroVention, Inc. (2010) Summary page 1.
- K080666: Hydrosoft and Hydrosoft Plus Embolization Coil Systems, MicroVention, Inc. (2008) Summary page 1.

## Cited in the summary but kept off the family tree
- K080241: DDS Stabilization System, Paradigm Spine, LLC (2008). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- 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

## Recalls of this device
- Nov 22, 2019 · Class II · Z-1403-2020: The devices may be missing the implant coil.
- Nov 22, 2019 · Class II · Z-1404-2020: The devices may be missing the implant coil.
- Nov 22, 2019 · Class II · Z-1399-2020: The devices may be missing the implant coil.
- Nov 22, 2019 · Class II · Z-1407-2020: The devices may be missing the implant coil.
- Nov 22, 2019 · Class II · Z-1405-2020: The devices may be missing the implant coil.
- Nov 22, 2019 · Class II · Z-1394-2020: The devices may be missing the implant coil.
- Nov 22, 2019 · Class II · Z-1400-2020: The devices may be missing the implant coil.
- Nov 22, 2019 · Class II · Z-1401-2020: The devices may be missing the implant coil.
- Nov 22, 2019 · Class II · Z-1402-2020: The devices may be missing the implant coil.
- Nov 22, 2019 · Class II · Z-1406-2020: The devices may be missing the implant coil.
- Nov 22, 2019 · Class II · Z-1393-2020: The devices may be missing the implant coil.
- Nov 22, 2019 · Class II · Z-1392-2020: The devices may be missing the implant coil.
- Nov 22, 2019 · Class II · Z-1396-2020: The devices may be missing the implant coil.
- Nov 22, 2019 · Class II · Z-1397-2020: The devices may be missing the implant coil.
- Nov 22, 2019 · Class II · Z-1395-2020: The devices may be missing the implant coil.
- Nov 22, 2019 · Class II · Z-1398-2020: The devices may be missing the implant coil.

## Indications for use
Intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. Also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.

Source page: https://510kreport.com/device/K132952
Methodology: https://510kreport.com/methodology