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FDA 510(k)

CONCERTO DETACHABLE COIL SYSTEM

K-Number: K090046 · 2009-02-27

ApplicantMicro Therapeutics, Inc.
Decision Date2009-02-27
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CONCERTO DETACHABLE COIL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Micro Therapeutics, Inc.. It received FDA 510(k) clearance on 2009-02-27 under 510(k) number K090046. 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 CONCERTO DETACHABLE COIL SYSTEM?

CONCERTO DETACHABLE COIL SYSTEM is a medical device that received FDA 510(k) clearance on 2009-02-27. The listed applicant is Micro Therapeutics, Inc.. The 510(k) number is K090046.

When did CONCERTO DETACHABLE COIL SYSTEM receive FDA 510(k) clearance?

CONCERTO DETACHABLE COIL SYSTEM received FDA 510(k) clearance on 2009-02-27, under 510(k) number K090046.

Who is the listed applicant for CONCERTO DETACHABLE COIL SYSTEM?

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

What is the FDA product code for CONCERTO DETACHABLE COIL SYSTEM?

The FDA product code for CONCERTO DETACHABLE COIL SYSTEM is KRD.

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Other records listing Micro Therapeutics, Inc. as applicant

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.

K113289ORION MICRO CATHETERK11345414 WIRE STANDARD, 14 WIRE LSK090870ECHELON MICRO CATHETER, MODELS 105-5092-150SA, 145-5092-150SA AND 190-5092-150SA AND SYRINGE ADAPTER ACCESSORYK081465AXIUM DETACHABLE COIL SYSTEMK060747FX DETACHABLE COIL SYSTEMK060625NEXUS DETACHABLE COIL SYSTEM, MORPHEUS 3D CSR

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Related Devices (Code: KRD)

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.

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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