FDA 510(k)

NumenコイルエMBOLイゼーションシステム；NumenFR分離システム

K番号: K203625 · 2021-09-01

申請者MicroPort NeuroTech (Shanghai) Co., Ltd.

決定日2021-09-01

製品コードHCG

諮問委員会Please provide the source text to translate.

決定大幅同等

医療機器の概要

Numen Coil Embolization System; NumenFR Detachment System is the device name listed in this FDA 510(k) record. The listed applicant is MicroPort NeuroTech (Shanghai) Co., Ltd.. It received FDA 510(k) clearance on 2021-09-01 under 510(k) number K203625. The device is classified under product code HCG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Numen Coil Embolization System; NumenFR Detachment System?

Numen Coil Embolization System; NumenFR Detachment System is a medical device that received FDA 510(k) clearance on 2021-09-01. The listed applicant is MicroPort NeuroTech (Shanghai) Co., Ltd.. The 510(k) number is K203625.

When did Numen Coil Embolization System; NumenFR Detachment System receive FDA 510(k) clearance?

Numen Coil Embolization System; NumenFR Detachment System received FDA 510(k) clearance on 2021-09-01, under 510(k) number K203625.

Who is the listed applicant for Numen Coil Embolization System; NumenFR Detachment System?

The FDA 510(k) record lists MicroPort NeuroTech (Shanghai) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Numen Coil Embolization System; NumenFR Detachment System?

The FDA product code for Numen Coil Embolization System; NumenFR Detachment System is HCG.

申請者としてMicroPort NeuroTech (Shanghai) Co., Ltd.を記載するその他の記録

K260351Numen™ヘリアコイルエンブリゼーションシステム；NumenFR™分離システム K242154Numen™コイルエンブリゼーションシステム；NumenFR™分離システム K232955NumenコイルエMBOLイゼーションシステム；NumenFR分離システム

公式ソース

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