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FDA 510(k)

MICROPLEX COIL SYSTEM- COSMOS

K-Number: K102365 · 2010-11-18

ApplicantMicroVention, Inc.
Decision Date2010-11-18
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MICROPLEX COIL SYSTEM- COSMOS is the device name listed in this FDA 510(k) record. The listed applicant is MicroVention, Inc.. It received FDA 510(k) clearance on 2010-11-18 under 510(k) number K102365. The device is classified under product code KRD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROPLEX COIL SYSTEM- COSMOS?

MICROPLEX COIL SYSTEM- COSMOS is a medical device that received FDA 510(k) clearance on 2010-11-18. The listed applicant is MicroVention, Inc.. The 510(k) number is K102365.

When did MICROPLEX COIL SYSTEM- COSMOS receive FDA 510(k) clearance?

MICROPLEX COIL SYSTEM- COSMOS received FDA 510(k) clearance on 2010-11-18, under 510(k) number K102365.

Who is the listed applicant for MICROPLEX COIL SYSTEM- COSMOS?

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- COSMOS?

The FDA product code for MICROPLEX COIL SYSTEM- COSMOS is KRD.

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Related Devices (Code: KRD)

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K252812UniPearls® Embolic MicrospheresSuzhou Haowei Medical Technology Co., Ltd.K261488OBSIDIO Conformable EmbolicBoston Scientific CorporationK261866Concerto Versa™ Detachable CoilMedtronic, Inc.K260635HARBOR Occlusion DeviceNuvascular, Inc.K260508LOBO Vascular Occlusion SystemOkami Medical, Inc.K253511Concerto Versa™ Detachable CoilMedtronic, 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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