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FDA 510(k)

Numen Coil Embolization System; NumenFR Detachment System

K-Number: K203625 · 2021-09-01

Decision Date2021-09-01
Product CodeHCG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing MicroPort NeuroTech (Shanghai) Co., Ltd. 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.

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.

Official Source

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