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FDA 510(k)

MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)

K-Number: K153594 · 2016-01-22

ApplicantMicroVention, Inc.
Decision Date2016-01-22
Product CodeHCG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES) is a medical device manufactured by MicroVention, Inc.. It received FDA 510(k) clearance on 2016-01-22 under approval number K153594. The device is classified under product code HCG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)?

MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES) is a medical device that received FDA 510(k) clearance on 2016-01-22. It is manufactured by MicroVention, Inc.. The 510(k) number is K153594.

When was MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES) approved by the FDA?

MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES) received FDA 510(k) clearance on 2016-01-22, under approval number K153594.

What company makes MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)?

MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES) is manufactured by MicroVention, Inc..

What is the FDA product code for MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)?

The FDA product code for MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES) is HCG.

Related Clinical Trials

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Other Devices by MicroVention, Inc.

K163154Traxcess 7 Mini XSoft Guidewire K161803Traxcess .007 Mini Guidewire K161367HydroCoil Embolic System (HES) K161452MicroPlex Coil System (MCS) - HyperSoft 3D K162999V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System K162524AZUR CX Detachable 18 Peripheral Coil System

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Related Devices (Code: HCG)

K161367HydroCoil Embolic System (HES)MicroVention, Inc. K161452MicroPlex Coil System (MCS) - HyperSoft 3DMicroVention, Inc. K161429Target Detachable CoilsStryker Neurovascular K153658Target Detachable CoilsStryker Neurovascular K160832Penumbra Smart CoilPenumbra, Inc. K160096InZone Detachment SystemStryker Neurovascular

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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