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FDA 510(k)

MicroPlex Coil System (MCS) - HyperSoft 3D

K-Number: K161452 · 2016-08-31

ApplicantMicroVention, Inc.
Decision Date2016-08-31
Product CodeHCG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MicroPlex Coil System (MCS) - HyperSoft 3D is a medical device manufactured by MicroVention, Inc.. It received FDA 510(k) clearance on 2016-08-31 under approval number K161452. 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) - HyperSoft 3D?

MicroPlex Coil System (MCS) - HyperSoft 3D is a medical device that received FDA 510(k) clearance on 2016-08-31. It is manufactured by MicroVention, Inc.. The 510(k) number is K161452.

When was MicroPlex Coil System (MCS) - HyperSoft 3D approved by the FDA?

MicroPlex Coil System (MCS) - HyperSoft 3D received FDA 510(k) clearance on 2016-08-31, under approval number K161452.

What company makes MicroPlex Coil System (MCS) - HyperSoft 3D?

MicroPlex Coil System (MCS) - HyperSoft 3D is manufactured by MicroVention, Inc..

What is the FDA product code for MicroPlex Coil System (MCS) - HyperSoft 3D?

The FDA product code for MicroPlex Coil System (MCS) - HyperSoft 3D is HCG.

Other Devices by MicroVention, Inc.

K163154Traxcess 7 Mini XSoft Guidewire K161803Traxcess .007 Mini Guidewire K161367HydroCoil Embolic System (HES) K153594MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES) 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. K161429Target Detachable CoilsStryker Neurovascular K153658Target Detachable CoilsStryker Neurovascular K160832Penumbra Smart CoilPenumbra, Inc. K160096InZone Detachment SystemStryker Neurovascular K153594MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)MicroVention, Inc.

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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