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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 the device name listed in this FDA 510(k) record. The listed applicant is MicroVention, Inc.. It received FDA 510(k) clearance on 2016-01-22 under 510(k) 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. The listed applicant is MicroVention, Inc.. The 510(k) number is K153594.

When did MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES) receive FDA 510(k) clearance?

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

Who is the listed applicant for MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)?

The FDA 510(k) record lists MicroVention, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

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Related Devices (Code: HCG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262419MICRUSFRAME (MFR100202); MICRUSFRAME (MFR100253); MICRUSFRAME (MFR100305); MICRUSFRAME (MFR100356); MICRUSFRAME (MFR100407); MICRUSFRAME (MFR100412); MICRUSFRAME (MFR100509); MICRUSFRAME (MFR100517); MICRUSFRAME (MFR100611); MICRUSFRAME (MFR100626); MICRUSFRAME (MFR100713); MICRUSFRAME (MFR100730); MICRUSFRAME (MFR100816); MICRUSFRAME (MFR100829); MICRUSFRAME (MFR140225); MICRUSFRAME (MFR140303); MICRUSFRAME (MFR140304); MICRUSFRAME (MFR140306); MICRUSFRAME (MFR140406); MICRUSFRAME (MFCerenovus, Inc.K261772Target Xtra Detachable CoilStryker NeurovscularK260351Numen™ Helia Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.K254221Optima Coil System (OptiOne Coil System)Balt USA, LLCK252694Target Detachable CoilStryker NeurovascularK251832InZone IST Detachment System; IZDS Connecting CableStryker 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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