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FDA 510(k)

HydroCoil Embolic System (HES)

K-Number: K161367 · 2016-08-31

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

Device Summary

HydroCoil Embolic System (HES) is a medical device manufactured by MicroVention, Inc.. It received FDA 510(k) clearance on 2016-08-31 under approval number K161367. 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 HydroCoil Embolic System (HES)?

HydroCoil Embolic System (HES) 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 K161367.

When was HydroCoil Embolic System (HES) approved by the FDA?

HydroCoil Embolic System (HES) received FDA 510(k) clearance on 2016-08-31, under approval number K161367.

What company makes HydroCoil Embolic System (HES)?

HydroCoil Embolic System (HES) is manufactured by MicroVention, Inc..

What is the FDA product code for HydroCoil Embolic System (HES)?

The FDA product code for HydroCoil Embolic System (HES) is HCG.

Related Clinical Trials

NCT07541404 MMA Embolization With NeoCast for Subacute and Chronic Subdural Hematoma NOT_YET_RECRUITING NCT07276711 CAPTURE-2: Controlled Arterial Protection to Ultimately Remove Embolic Material RECRUITING NCT06735833 MMA Embolization for Refractory Chronic Migraine RECRUITING NCT03731000 PHIL® Embolic System Pediatric IDE RECRUITING

Other Devices by MicroVention, Inc.

K163154Traxcess 7 Mini XSoft Guidewire K161803Traxcess .007 Mini Guidewire K161452MicroPlex Coil System (MCS) - HyperSoft 3D 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)

K161452MicroPlex Coil System (MCS) - HyperSoft 3DMicroVention, 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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