Class Class II

Numen™ Coil Embolization System; NumenFR™ Detachment System (K242154)

K242154 2024-09-30 Special
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Description

Numen™ Coil Embolization System; NumenFR™ Detachment System by MicroPort NeuroTech (Shanghai) Co., Ltd., an FDA 510(k) cleared neurology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK242154
Clearance Date2024-09-30
Clearance TypeSpecial
Product CodeHCG
Regulation Number882.5950

Categories

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Predicate lineage for K242154

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Numen™ Coil Embolization System; NumenFR™ Detachment System (K242154) cites 1 predicate device and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K232955Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co.,...2024

Trace the full predicate network for K242154

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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